Hip

PHILADELPHIA – Preoperative neuromuscular exercise does not significantly improve function or pain 3 months after total hip or knee replacement, according to a randomized, controlled trial in 165 patients.

The study’s primary endpoint of self-reported activities of daily living (ADLs) at 3 months was similar in patients who exercised prior to surgery and those who did not (mean between-group difference 4.4 points; P = .096). The change from baseline in the group who exercised prior to surgery was 29 points vs. 25 points in the surgery-only group, on a 100-point, worst-to-best scale.

Patrice Wendling/IMNG Medical Media

Joint-related quality of life (mean 4.5 points; P = .22) and pain (mean 3.6 points; P = .09) were also not significantly different between the two groups, Dr. Allan Villadsen said at the World Congress on Osteoarthritis Research Society.

The 8 weeks of twice-weekly exercise, however, was not for naught.

Patients improved immediately following exercise and this improvement carried over to 6 weeks after surgery, "indicating an earlier onset of recovery," he said. "Therefore, we believe exercise constitutes a viable treatment option for the individual patient who’s willing to engage in exercise prior to total hip or knee replacement and possibly obtain an earlier onset of recovery."

While preoperative exercise has been shown to improve function in other settings, little is known about its role in knee- and hip-replacement surgery for patients with severe osteoarthritis (OA). A meta-analysis of 23 randomized controlled trials involving 1,461 patients reported a small improvement in physical function and pain 3 weeks after total hip arthroscopy, but no effects in total knee replacement 3 months after surgery (Osteoarthritis Cartilage 2011;19:1381-95).A subsequent systematic review and meta-analysis, however, suggests that the therapeutic validity of the exercise programs used in the studies may have hampered the beneficial effects (PLos One 2012;7:e38031). In addition, the sample sizes were small, and the calculated effect sizes for pain and physical function were based on only two to four studies, observed Dr. Villadsen of the Institute of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense.

The current trial randomly assigned 165 patients with severe symptomatic hip or knee OA scheduled for unilateral primary total joint replacement to receive a brochure recommending exercise prior to surgery and a 3-hour information session with health professionals or the same intervention plus individualized group-based neuromuscular exercise guided by a physiotherapist. The sessions were designed to improve sensorimotor control and range of motion, and included warm up on a stationary bike, a circuit program, and a walking cool-down period, Dr. Villadsen said at the meeting, sponsored by Osteoarthritis Research Society International (OARSI).

Hip OA was present in 43 of the 84 patients in the exercise arm and 41 of the 81 controls. Their mean age was 67 years and mean ADL score on the 100-point Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires was 50.6 and 45.6, respectively.

At 6 weeks, the between-group difference in activities of daily living on both the HOOS and KOOS questionnaires was 5.2, favoring the exercise group (P = .05), Dr. Villadsen said.

During a discussion of the results, an audience member asked whether the patients had tried exercise prior to joint replacement, which is the current recommendation. Dr. Villadsen said they did not track this, but that anecdotally, "Many of these patients are not offered what is recommended in the international guidelines, which is very disturbing ... if you asked them, many of them never even exercised before."

Session moderator and orthopedic surgeon Dr. Victor Goldberg, with Case Western Reserve University in Cleveland said it’s difficult to tease out the effects of surgery in analyses like these, but agreed that many patients are being sent to surgery without having been counseled to exercise. Part of the problem is that patients with mild to moderate OA are typically cared for by primary care physicians, who aren’t as well versed as rheumatologists and orthopedic surgeons are on the impairment, he said in an interview.

"That’s one of the charges of OARSI and our guidelines, is to really put it out in the community," he added.

"These kinds of studies, which point to the need for intervention in arthroplasty, particularly with well-done neuromuscular exercise programs, are very important to the overall management of these patients," Dr. Goldberg said. It’s needed because 15%-23% of patients after surgery say " ‘I’m not much better; I still hurt.’ "

Self-reported data at 1 year are currently being processed and will be included in a manuscript on the cost-effectiveness of the intervention, Dr. Villadsen said in an interview.

Dr. Villadsen reported having no financial disclosures.

[email protected]

PHILADELPHIA – Preoperative neuromuscular exercise does not significantly improve function or pain 3 months after total hip or knee replacement, according to a randomized, controlled trial in 165 patients.

The study’s primary endpoint of self-reported activities of daily living (ADLs) at 3 months was similar in patients who exercised prior to surgery and those who did not (mean between-group difference 4.4 points; P = .096). The change from baseline in the group who exercised prior to surgery was 29 points vs. 25 points in the surgery-only group, on a 100-point, worst-to-best scale.

Patrice Wendling/IMNG Medical Media

Joint-related quality of life (mean 4.5 points; P = .22) and pain (mean 3.6 points; P = .09) were also not significantly different between the two groups, Dr. Allan Villadsen said at the World Congress on Osteoarthritis Research Society.

The 8 weeks of twice-weekly exercise, however, was not for naught.

Patients improved immediately following exercise and this improvement carried over to 6 weeks after surgery, "indicating an earlier onset of recovery," he said. "Therefore, we believe exercise constitutes a viable treatment option for the individual patient who’s willing to engage in exercise prior to total hip or knee replacement and possibly obtain an earlier onset of recovery."

While preoperative exercise has been shown to improve function in other settings, little is known about its role in knee- and hip-replacement surgery for patients with severe osteoarthritis (OA). A meta-analysis of 23 randomized controlled trials involving 1,461 patients reported a small improvement in physical function and pain 3 weeks after total hip arthroscopy, but no effects in total knee replacement 3 months after surgery (Osteoarthritis Cartilage 2011;19:1381-95).A subsequent systematic review and meta-analysis, however, suggests that the therapeutic validity of the exercise programs used in the studies may have hampered the beneficial effects (PLos One 2012;7:e38031). In addition, the sample sizes were small, and the calculated effect sizes for pain and physical function were based on only two to four studies, observed Dr. Villadsen of the Institute of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense.

The current trial randomly assigned 165 patients with severe symptomatic hip or knee OA scheduled for unilateral primary total joint replacement to receive a brochure recommending exercise prior to surgery and a 3-hour information session with health professionals or the same intervention plus individualized group-based neuromuscular exercise guided by a physiotherapist. The sessions were designed to improve sensorimotor control and range of motion, and included warm up on a stationary bike, a circuit program, and a walking cool-down period, Dr. Villadsen said at the meeting, sponsored by Osteoarthritis Research Society International (OARSI).

Hip OA was present in 43 of the 84 patients in the exercise arm and 41 of the 81 controls. Their mean age was 67 years and mean ADL score on the 100-point Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires was 50.6 and 45.6, respectively.

At 6 weeks, the between-group difference in activities of daily living on both the HOOS and KOOS questionnaires was 5.2, favoring the exercise group (P = .05), Dr. Villadsen said.

During a discussion of the results, an audience member asked whether the patients had tried exercise prior to joint replacement, which is the current recommendation. Dr. Villadsen said they did not track this, but that anecdotally, "Many of these patients are not offered what is recommended in the international guidelines, which is very disturbing ... if you asked them, many of them never even exercised before."

Session moderator and orthopedic surgeon Dr. Victor Goldberg, with Case Western Reserve University in Cleveland said it’s difficult to tease out the effects of surgery in analyses like these, but agreed that many patients are being sent to surgery without having been counseled to exercise. Part of the problem is that patients with mild to moderate OA are typically cared for by primary care physicians, who aren’t as well versed as rheumatologists and orthopedic surgeons are on the impairment, he said in an interview.

"That’s one of the charges of OARSI and our guidelines, is to really put it out in the community," he added.

"These kinds of studies, which point to the need for intervention in arthroplasty, particularly with well-done neuromuscular exercise programs, are very important to the overall management of these patients," Dr. Goldberg said. It’s needed because 15%-23% of patients after surgery say " ‘I’m not much better; I still hurt.’ "

Self-reported data at 1 year are currently being processed and will be included in a manuscript on the cost-effectiveness of the intervention, Dr. Villadsen said in an interview.

Dr. Villadsen reported having no financial disclosures.

[email protected]

PHILADELPHIA – Preoperative neuromuscular exercise does not significantly improve function or pain 3 months after total hip or knee replacement, according to a randomized, controlled trial in 165 patients.

The study’s primary endpoint of self-reported activities of daily living (ADLs) at 3 months was similar in patients who exercised prior to surgery and those who did not (mean between-group difference 4.4 points; P = .096). The change from baseline in the group who exercised prior to surgery was 29 points vs. 25 points in the surgery-only group, on a 100-point, worst-to-best scale.

Patrice Wendling/IMNG Medical Media

Joint-related quality of life (mean 4.5 points; P = .22) and pain (mean 3.6 points; P = .09) were also not significantly different between the two groups, Dr. Allan Villadsen said at the World Congress on Osteoarthritis Research Society.

The 8 weeks of twice-weekly exercise, however, was not for naught.

Patients improved immediately following exercise and this improvement carried over to 6 weeks after surgery, "indicating an earlier onset of recovery," he said. "Therefore, we believe exercise constitutes a viable treatment option for the individual patient who’s willing to engage in exercise prior to total hip or knee replacement and possibly obtain an earlier onset of recovery."

While preoperative exercise has been shown to improve function in other settings, little is known about its role in knee- and hip-replacement surgery for patients with severe osteoarthritis (OA). A meta-analysis of 23 randomized controlled trials involving 1,461 patients reported a small improvement in physical function and pain 3 weeks after total hip arthroscopy, but no effects in total knee replacement 3 months after surgery (Osteoarthritis Cartilage 2011;19:1381-95).A subsequent systematic review and meta-analysis, however, suggests that the therapeutic validity of the exercise programs used in the studies may have hampered the beneficial effects (PLos One 2012;7:e38031). In addition, the sample sizes were small, and the calculated effect sizes for pain and physical function were based on only two to four studies, observed Dr. Villadsen of the Institute of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense.

The current trial randomly assigned 165 patients with severe symptomatic hip or knee OA scheduled for unilateral primary total joint replacement to receive a brochure recommending exercise prior to surgery and a 3-hour information session with health professionals or the same intervention plus individualized group-based neuromuscular exercise guided by a physiotherapist. The sessions were designed to improve sensorimotor control and range of motion, and included warm up on a stationary bike, a circuit program, and a walking cool-down period, Dr. Villadsen said at the meeting, sponsored by Osteoarthritis Research Society International (OARSI).

Hip OA was present in 43 of the 84 patients in the exercise arm and 41 of the 81 controls. Their mean age was 67 years and mean ADL score on the 100-point Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires was 50.6 and 45.6, respectively.

At 6 weeks, the between-group difference in activities of daily living on both the HOOS and KOOS questionnaires was 5.2, favoring the exercise group (P = .05), Dr. Villadsen said.

During a discussion of the results, an audience member asked whether the patients had tried exercise prior to joint replacement, which is the current recommendation. Dr. Villadsen said they did not track this, but that anecdotally, "Many of these patients are not offered what is recommended in the international guidelines, which is very disturbing ... if you asked them, many of them never even exercised before."

Session moderator and orthopedic surgeon Dr. Victor Goldberg, with Case Western Reserve University in Cleveland said it’s difficult to tease out the effects of surgery in analyses like these, but agreed that many patients are being sent to surgery without having been counseled to exercise. Part of the problem is that patients with mild to moderate OA are typically cared for by primary care physicians, who aren’t as well versed as rheumatologists and orthopedic surgeons are on the impairment, he said in an interview.

"That’s one of the charges of OARSI and our guidelines, is to really put it out in the community," he added.

"These kinds of studies, which point to the need for intervention in arthroplasty, particularly with well-done neuromuscular exercise programs, are very important to the overall management of these patients," Dr. Goldberg said. It’s needed because 15%-23% of patients after surgery say " ‘I’m not much better; I still hurt.’ "

Self-reported data at 1 year are currently being processed and will be included in a manuscript on the cost-effectiveness of the intervention, Dr. Villadsen said in an interview.

Dr. Villadsen reported having no financial disclosures.

[email protected]

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

BIRMINGHAM, ENGLAND – Long-term bisphosphonate use reduced the risk for joint implant failure and subsequent hip or knee revision survey in 40% of patients in a large, retrospective, observational study.

The rate for revision surgery at a median of 2.6 years’ follow-up was 1.88% in the 1,911 participants who had taken bisphosphonates for at least 6 months, compared with 4.36% in the 10,755 nonbisphosphonate users (hazard ratio, 0.62).

"The observed effect size is stronger in patients with higher therapy duration and adherence," Dr. Daniel Prieto-Alhambra reported at the annual meeting of the British Society for Rheumatology.

"This association does not differ by age, gender, joint replaced, or fracture history," added Dr. Prieto-Alhambra, senior clinical research fellow from the Nuffield department of orthopaedics, rheumatology, and musculoskeletal sciences at the University of Oxford, England.

Osteolysis and aseptic loosening are the most common causes of revision surgery, the researcher noted, adding that bisphosphonates have antiosteoclast activity that may have potential benefits on implant survival.

"Patients need to be on treatment for at least 6 months for the drug to be effective," Dr. Prieto-Alhambra emphasized. He later said after his presentation that data from a sub-analysis suggest that patients benefit further if they started therapy in the weeks following surgery.*

Data used in the study were obtained from Danish nationwide health registries on more than 80,000 patients aged 40 years or older who had total hip arthroplasty (THA) or total knee arthroplasty (TKA) in Denmark between 1998 and 2007. Patients were excluded if they had experienced a prior hip fracture; had inflammatory arthritis or used disease-modifying antirheumatic drugs; or had Paget’s disease, bone cancer, or metastasis. Baseline characteristics of those who did and those who did not use bisphosphonates were comparable except for calcium and vitamin D supplementation, which was higher in the bisphosphonate-treated group (9.9% vs. 4.8%).

The longer the duration of treatment, the less chance there was for implant failure: 5 implants failed in 352 (1.4%) patients treated with bisphosphonates for more than 2 years (HR, 0.53); 16 (1.6%) in 1,006 patients treated for 1-2 years (HR, 0.52); and 15 (2.7%) in 553 patients treated for 6-12 months (HR, 1.31).

Adherence was assessed using a medication possession ratio (MPR), with lower MPR values indicating poorer adherence. Failure rates were 3%, 2.9%, and 1.5% for MPRs of less than 0.5 (HR, 0.93), 0.5-0.79 (HR, 0.48), and 0.8 or greater (HR, 0.56), respectively.

The study’s findings support those of a recent U.K. population-based, retrospective cohort study (BMJ 2011 [doi:10.1136/bmj.d7222]) that involved more than 41,000 primary THA/TKA patients.

The U.K. data showed that fewer surgical revisions occurred at 5 years in bisphosphonate users (0.93% vs. 1.96% in nonusers), and that there was a 46% decrease in the risk of revision surgery (HR for implant survival of 0.54; P = .047). It was also estimated, however, that at least 107 patients would need to be treated with bisphosphonates to avoid one revision surgery.

Osteoarthritis accounts for more than 90% of THAs and TKAs performed in the United Kingdom, with 1 in 75 patients experiencing implant failure and revision surgery within 3 years of the index surgery. Such surgery is associated with a worse clinical outcome than the primary procedure, and it is also associated with greater health care costs (PLoS Med. 2008;5:e179). Bisphosphonates could potentially offer a simple and hopefully cost-effective solution to reducing the likelihood of such surgery.

"Confirmation in a randomized controlled trial is needed to test the efficacy of bisphosphonates to improve implant survival, Dr. Prieto-Alhambra said.

A 40% reduction in the risk of aseptic loosening of the prosthesis is potentially very good news for patients, observed Dr. Ken Poole, a clinical lecturer at the University of Cambridge, England. Randomized trial data would be welcomed and warranted, he added.

Dr. Poole, who was chairing the session at which these data were presented, highlighted that this was another "good news" story for bisphosphonates, adding to recent evidence that they increased survival after hip fracture and have also been associated with reductions in the incidence of certain cancers.

"Many of my patients are well versed in the potential harms of bisphosphonate treatments for osteoporosis, often because of enthusiastic media coverage of the ‘bad news’ aspect," he said in an interview.

"The upshot is that ‘at-risk’ patients are increasingly reluctant to commence therapy; indeed, it is easy to find out about rare and frightening side effects like osteonecrosis of the jaw and atraumatic fractures of the femur from a few clicks on the Internet," Dr. Poole commented.

Although serious adverse events should be borne in mind when considering treatment choice, Dr. Poole noted that bisphosphonates were effective for osteoporosis in the right patients, and that Dr. Prieto-Alhambra’s study was one of several identifying additional health benefits in patients undergoing total hip or knee replacement.

A poor public perception of bisphosphonates could influence adherence, and there is recent evidence that only 30% of women actually take their prescriptions to the pharmacist (Osteoporos. Int. 2013 [doi:10.1007/s00198-013-2326-5]). Concern over calcium supplementation causing heart attacks and stroke might also be a factor, as this, together with vitamin D, goes along with bisphosphonate use. Indeed, a study of 233 women taking bisphosphonates for osteoporosis also presented at the British Society for Rheumatology meeting found that a lack of concomitant calcium and vitamin D supplementation was predictive of poor adherence (Rheumatology 2013;52[Suppl. 1]:i116-7; abstract 163). Other predictive factors were older age and the use of sleeping tablets.

Dr. Prieto-Alhambra and Dr. Poole had no conflicts of interests.

* Revised, 5/1/13

GAITHERSBURG, MD. – Evaluation of patients for adverse effects associated with a metal-on-metal hip implant should include an expedited physical exam with an orthopedic surgeon, routine x-rays, and both standard and specialized laboratory tests, a Food and Drug Administration advisory panel recommended at the end of a 2-day meeting on June 28.

Lab testing should include the standard blood tests, as well as measures of sedimentation rate and C-reactive protein level, and more sophisticated imaging with MRI or CT, if needed, according to the advisory panel of the FDA’s Orthopaedic and Rehabilitation Devices Panel, which met for 2 days to review the safety data on these devices.

Blood or serum tests for metal ions (cobalt and chromium, which have been elevated in some patients who have received metal-on-metal devices, and have been associated with device failures) also can be helpful, panelists said, although these tests are not universally available and how to use the results in determining the course of treatment is still unclear. They made similar recommendations on how to follow up symptomatic patients who have undergone hip resurfacing with a metal-on-metal device.

There was less consensus on how to follow patients who have received one of these devices but are asymptomatic; recommendations included obtaining a baseline evaluation, with an MRI (at least in patients who are part of a postmarketing study) and tests for metal ions so changes can be monitored and compared over time. One panelist called for longitudinal studies that collect this type of information at baseline, so that predictive factors for failure could be identified.

The panel was not asked to vote on any issues, only to provide advice, so that the agency can make recommendations on the safety of these devices to health care providers and patients. The agency usually follows the recommendations of its advisory panels.

Metal-on-metal hip resurfacing systems, which became popular for use in younger active patients who had healthier bone, include the femoral head with a metal covering, a femoral stem, and an acetabular component. The metal-on metal hip devices were thought to last longer. The proportion of procedures in which devices are used has declined in reaction to increased revision rates and reports of adverse events.

In May 2011, the FDA issued a public health communication regarding adverse event reports associated with these devices and subsequently ordered manufacturers to conduct post-marketing studies addressing the safety issues of their metal-on-metal total hip replacement devices. The FDA has recalled two metal-on-metal devices, including one in August 2010 for a higher than expected revision rate.

A review of metal-on metal implants in December 2011 conducted by the American Academy of Orthopaedic Surgeons concluded that the risk of revision was higher among patients who receive these implants for total hip arthroplasty and hip resurfacing than those who undergo this surgery using a different bearing. The AAOS review also found that larger femoral head components used in hip arthroplasty are associated with higher revision rates, which was also reported by speakers during the FDA panel meeting.

Alerts about local and soft tissue reactions and recommendations on metal ion testing and imaging of patients who have received one of these devices has been issued in the United Kingdom, Australia, and Canada.

When asked if they could describe any types of patients for whom the benefits of a metal-on-metal device for resurfacing or hip replacement outweigh the risks, panelists said that the decision should be up to the individual surgeon and that there might be some cases where this type of device may be useful. But the orthopedic surgeons on the panel said they rarely or never used metal-on metal implants because of these adverse event reports and availability of other options.

"I see no indication for which I would use a metal on metal [device] over any other technology," said the panel chair, Dr. William Rohr, an orthopedic surgeon who practices in Fort Bragg, Calif. He added that he had not seen any evidence indicating that the performance of the metal-on-metal devices was better than that of other options, and he considered any increased risk over the others available unacceptable, and pointed out gender differences, with women at risk of poorer outcomes

Members of FDA panels have been cleared of potential conflicts of interest; in some cases, they are given waivers but not at this meeting.

GAITHERSBURG, MD. – Evaluation of patients for adverse effects associated with a metal-on-metal hip implant should include an expedited physical exam with an orthopedic surgeon, routine x-rays, and both standard and specialized laboratory tests, a Food and Drug Administration advisory panel recommended at the end of a 2-day meeting on June 28.

Lab testing should include the standard blood tests, as well as measures of sedimentation rate and C-reactive protein level, and more sophisticated imaging with MRI or CT, if needed, according to the advisory panel of the FDA’s Orthopaedic and Rehabilitation Devices Panel, which met for 2 days to review the safety data on these devices.

Blood or serum tests for metal ions (cobalt and chromium, which have been elevated in some patients who have received metal-on-metal devices, and have been associated with device failures) also can be helpful, panelists said, although these tests are not universally available and how to use the results in determining the course of treatment is still unclear. They made similar recommendations on how to follow up symptomatic patients who have undergone hip resurfacing with a metal-on-metal device.

There was less consensus on how to follow patients who have received one of these devices but are asymptomatic; recommendations included obtaining a baseline evaluation, with an MRI (at least in patients who are part of a postmarketing study) and tests for metal ions so changes can be monitored and compared over time. One panelist called for longitudinal studies that collect this type of information at baseline, so that predictive factors for failure could be identified.

The panel was not asked to vote on any issues, only to provide advice, so that the agency can make recommendations on the safety of these devices to health care providers and patients. The agency usually follows the recommendations of its advisory panels.

Metal-on-metal hip resurfacing systems, which became popular for use in younger active patients who had healthier bone, include the femoral head with a metal covering, a femoral stem, and an acetabular component. The metal-on metal hip devices were thought to last longer. The proportion of procedures in which devices are used has declined in reaction to increased revision rates and reports of adverse events.

In May 2011, the FDA issued a public health communication regarding adverse event reports associated with these devices and subsequently ordered manufacturers to conduct post-marketing studies addressing the safety issues of their metal-on-metal total hip replacement devices. The FDA has recalled two metal-on-metal devices, including one in August 2010 for a higher than expected revision rate.

A review of metal-on metal implants in December 2011 conducted by the American Academy of Orthopaedic Surgeons concluded that the risk of revision was higher among patients who receive these implants for total hip arthroplasty and hip resurfacing than those who undergo this surgery using a different bearing. The AAOS review also found that larger femoral head components used in hip arthroplasty are associated with higher revision rates, which was also reported by speakers during the FDA panel meeting.

Alerts about local and soft tissue reactions and recommendations on metal ion testing and imaging of patients who have received one of these devices has been issued in the United Kingdom, Australia, and Canada.

When asked if they could describe any types of patients for whom the benefits of a metal-on-metal device for resurfacing or hip replacement outweigh the risks, panelists said that the decision should be up to the individual surgeon and that there might be some cases where this type of device may be useful. But the orthopedic surgeons on the panel said they rarely or never used metal-on metal implants because of these adverse event reports and availability of other options.

"I see no indication for which I would use a metal on metal [device] over any other technology," said the panel chair, Dr. William Rohr, an orthopedic surgeon who practices in Fort Bragg, Calif. He added that he had not seen any evidence indicating that the performance of the metal-on-metal devices was better than that of other options, and he considered any increased risk over the others available unacceptable, and pointed out gender differences, with women at risk of poorer outcomes

Members of FDA panels have been cleared of potential conflicts of interest; in some cases, they are given waivers but not at this meeting.

GAITHERSBURG, MD. – Evaluation of patients for adverse effects associated with a metal-on-metal hip implant should include an expedited physical exam with an orthopedic surgeon, routine x-rays, and both standard and specialized laboratory tests, a Food and Drug Administration advisory panel recommended at the end of a 2-day meeting on June 28.

Lab testing should include the standard blood tests, as well as measures of sedimentation rate and C-reactive protein level, and more sophisticated imaging with MRI or CT, if needed, according to the advisory panel of the FDA’s Orthopaedic and Rehabilitation Devices Panel, which met for 2 days to review the safety data on these devices.

Blood or serum tests for metal ions (cobalt and chromium, which have been elevated in some patients who have received metal-on-metal devices, and have been associated with device failures) also can be helpful, panelists said, although these tests are not universally available and how to use the results in determining the course of treatment is still unclear. They made similar recommendations on how to follow up symptomatic patients who have undergone hip resurfacing with a metal-on-metal device.

There was less consensus on how to follow patients who have received one of these devices but are asymptomatic; recommendations included obtaining a baseline evaluation, with an MRI (at least in patients who are part of a postmarketing study) and tests for metal ions so changes can be monitored and compared over time. One panelist called for longitudinal studies that collect this type of information at baseline, so that predictive factors for failure could be identified.

The panel was not asked to vote on any issues, only to provide advice, so that the agency can make recommendations on the safety of these devices to health care providers and patients. The agency usually follows the recommendations of its advisory panels.

Metal-on-metal hip resurfacing systems, which became popular for use in younger active patients who had healthier bone, include the femoral head with a metal covering, a femoral stem, and an acetabular component. The metal-on metal hip devices were thought to last longer. The proportion of procedures in which devices are used has declined in reaction to increased revision rates and reports of adverse events.

In May 2011, the FDA issued a public health communication regarding adverse event reports associated with these devices and subsequently ordered manufacturers to conduct post-marketing studies addressing the safety issues of their metal-on-metal total hip replacement devices. The FDA has recalled two metal-on-metal devices, including one in August 2010 for a higher than expected revision rate.

A review of metal-on metal implants in December 2011 conducted by the American Academy of Orthopaedic Surgeons concluded that the risk of revision was higher among patients who receive these implants for total hip arthroplasty and hip resurfacing than those who undergo this surgery using a different bearing. The AAOS review also found that larger femoral head components used in hip arthroplasty are associated with higher revision rates, which was also reported by speakers during the FDA panel meeting.

Alerts about local and soft tissue reactions and recommendations on metal ion testing and imaging of patients who have received one of these devices has been issued in the United Kingdom, Australia, and Canada.

When asked if they could describe any types of patients for whom the benefits of a metal-on-metal device for resurfacing or hip replacement outweigh the risks, panelists said that the decision should be up to the individual surgeon and that there might be some cases where this type of device may be useful. But the orthopedic surgeons on the panel said they rarely or never used metal-on metal implants because of these adverse event reports and availability of other options.

"I see no indication for which I would use a metal on metal [device] over any other technology," said the panel chair, Dr. William Rohr, an orthopedic surgeon who practices in Fort Bragg, Calif. He added that he had not seen any evidence indicating that the performance of the metal-on-metal devices was better than that of other options, and he considered any increased risk over the others available unacceptable, and pointed out gender differences, with women at risk of poorer outcomes

Members of FDA panels have been cleared of potential conflicts of interest; in some cases, they are given waivers but not at this meeting.

BARCELONA – People with knee and hip osteoarthritis tend to overstate their walking disability, but timed walking tests provide an accurate assessment of their lameness, according to a new study.

Dr. Luke Brunton, orthopedic surgeon and researcher at the musculoskeletal research unit at the University of Bristol (England), and his colleagues wanted to find out whether patient self-reports of walking could be used to accurately represent their walking ability. "We found a very poor correlation between self-reports and objective tests," said Dr. Brunton at the World Congress on Osteoarthritis.

He added that "the observers found that patients were performing much more easily than they reported. There was a much better correlation between the observers’ reports and the tests than the patient’s self-reported walking ability."

According to Dr. Brunton, walking impairment in patients with hip and knee OA was particularly important because it was part of the reason for patients’ reduced life span, is linked to social isolation, and has been associated with dementia.

"Questions on walking are very often used to assess function, quality of life, and disability in people with OA. People are commonly asked to self-report on either walking restrictions or distance limitations, however, simply asking patients may not give the whole picture," said Dr. Brunton.

The researchers looked at the correlations between self-reported walking ability and functional tests, and observers’ assessments and the same functional tests of walking ability.

Data from a large U.K. community based cohort study known as the South West and Avon Survey of Health (SASH) cohort were used including demographic and disease-related data.

Self-assessment questions were taken from the commonly used Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Lequesne assessment. WOMAC asked, ‘What degree of difficulty have you experienced walking on flat ground in the last week due to your hips or knees?’ while Lequesne asked, "What is the maximum distance you can walk with pain?"

The study involved 806 participants with a mean age of 68 years and body mass index of 28.6 kg/m². They were asked to carry out a timed 6-meter walking test and a "get up and go" test. The latter test times how long patients take to stand up from a sitting position, walk 3 meters, turn around, and sit down again.

In particular, research observers looked at whether patients had any difficulties walking and how far they said they could walk. They correlated these findings with the 6-meter walk and the "get-up and go" test results, and compared this to the correlation between patient self-reports and the same objective tests.

"We tell the observers it doesn’t matter how long the person is taking. The important thing is how easy it is for the patient to complete the test or not," explained Dr. Brunton.

A stronger association was found between observer evaluation of walking ability and the timed walk (ANOVA r2 = 0.58; P less than .001) and "get up and go" tests (ANOVA r2= 0.56; P less than .001), than patient self-reports (SF-36; ANOVA r2 = 0.23; P less than .001 and Lequesne ANOVA r2 = 0.27; P less than .001) with the objective tests. ANOVA r2 is a measure of the statistical correlation between the two variables

"It is notable that the observers were watching the patients actually carry out a test whereas patients were asked generally how well they walked," he continued, admitting it was a very different scenario being assessed. "But if you are only asking patients one question on walking you are assuming that their self-assessment and their functional test should be very similar. We have showed this isn’t the case."

The data showed most people did the test with similar times how they rated their own walking ability.

"You can’t just take a questionnaire but you may need to undertake a functional assessment too. Most clinicians would assess patients themselves rather than relying solely on questionnaires. For research, I think we also need a combination of the two methods," he said.

Dr. Brunton has reported no relevant financial disclosures. The meeting was sponsored by the Osteoarthritis Research Society International.

BARCELONA – People with knee and hip osteoarthritis tend to overstate their walking disability, but timed walking tests provide an accurate assessment of their lameness, according to a new study.

Dr. Luke Brunton, orthopedic surgeon and researcher at the musculoskeletal research unit at the University of Bristol (England), and his colleagues wanted to find out whether patient self-reports of walking could be used to accurately represent their walking ability. "We found a very poor correlation between self-reports and objective tests," said Dr. Brunton at the World Congress on Osteoarthritis.

He added that "the observers found that patients were performing much more easily than they reported. There was a much better correlation between the observers’ reports and the tests than the patient’s self-reported walking ability."

According to Dr. Brunton, walking impairment in patients with hip and knee OA was particularly important because it was part of the reason for patients’ reduced life span, is linked to social isolation, and has been associated with dementia.

"Questions on walking are very often used to assess function, quality of life, and disability in people with OA. People are commonly asked to self-report on either walking restrictions or distance limitations, however, simply asking patients may not give the whole picture," said Dr. Brunton.

The researchers looked at the correlations between self-reported walking ability and functional tests, and observers’ assessments and the same functional tests of walking ability.

Data from a large U.K. community based cohort study known as the South West and Avon Survey of Health (SASH) cohort were used including demographic and disease-related data.

Self-assessment questions were taken from the commonly used Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Lequesne assessment. WOMAC asked, ‘What degree of difficulty have you experienced walking on flat ground in the last week due to your hips or knees?’ while Lequesne asked, "What is the maximum distance you can walk with pain?"

The study involved 806 participants with a mean age of 68 years and body mass index of 28.6 kg/m². They were asked to carry out a timed 6-meter walking test and a "get up and go" test. The latter test times how long patients take to stand up from a sitting position, walk 3 meters, turn around, and sit down again.

In particular, research observers looked at whether patients had any difficulties walking and how far they said they could walk. They correlated these findings with the 6-meter walk and the "get-up and go" test results, and compared this to the correlation between patient self-reports and the same objective tests.

"We tell the observers it doesn’t matter how long the person is taking. The important thing is how easy it is for the patient to complete the test or not," explained Dr. Brunton.

A stronger association was found between observer evaluation of walking ability and the timed walk (ANOVA r2 = 0.58; P less than .001) and "get up and go" tests (ANOVA r2= 0.56; P less than .001), than patient self-reports (SF-36; ANOVA r2 = 0.23; P less than .001 and Lequesne ANOVA r2 = 0.27; P less than .001) with the objective tests. ANOVA r2 is a measure of the statistical correlation between the two variables

"It is notable that the observers were watching the patients actually carry out a test whereas patients were asked generally how well they walked," he continued, admitting it was a very different scenario being assessed. "But if you are only asking patients one question on walking you are assuming that their self-assessment and their functional test should be very similar. We have showed this isn’t the case."

The data showed most people did the test with similar times how they rated their own walking ability.

"You can’t just take a questionnaire but you may need to undertake a functional assessment too. Most clinicians would assess patients themselves rather than relying solely on questionnaires. For research, I think we also need a combination of the two methods," he said.

Dr. Brunton has reported no relevant financial disclosures. The meeting was sponsored by the Osteoarthritis Research Society International.

BARCELONA – People with knee and hip osteoarthritis tend to overstate their walking disability, but timed walking tests provide an accurate assessment of their lameness, according to a new study.

Dr. Luke Brunton, orthopedic surgeon and researcher at the musculoskeletal research unit at the University of Bristol (England), and his colleagues wanted to find out whether patient self-reports of walking could be used to accurately represent their walking ability. "We found a very poor correlation between self-reports and objective tests," said Dr. Brunton at the World Congress on Osteoarthritis.

He added that "the observers found that patients were performing much more easily than they reported. There was a much better correlation between the observers’ reports and the tests than the patient’s self-reported walking ability."

According to Dr. Brunton, walking impairment in patients with hip and knee OA was particularly important because it was part of the reason for patients’ reduced life span, is linked to social isolation, and has been associated with dementia.

"Questions on walking are very often used to assess function, quality of life, and disability in people with OA. People are commonly asked to self-report on either walking restrictions or distance limitations, however, simply asking patients may not give the whole picture," said Dr. Brunton.

The researchers looked at the correlations between self-reported walking ability and functional tests, and observers’ assessments and the same functional tests of walking ability.

Data from a large U.K. community based cohort study known as the South West and Avon Survey of Health (SASH) cohort were used including demographic and disease-related data.

Self-assessment questions were taken from the commonly used Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Lequesne assessment. WOMAC asked, ‘What degree of difficulty have you experienced walking on flat ground in the last week due to your hips or knees?’ while Lequesne asked, "What is the maximum distance you can walk with pain?"

The study involved 806 participants with a mean age of 68 years and body mass index of 28.6 kg/m². They were asked to carry out a timed 6-meter walking test and a "get up and go" test. The latter test times how long patients take to stand up from a sitting position, walk 3 meters, turn around, and sit down again.

In particular, research observers looked at whether patients had any difficulties walking and how far they said they could walk. They correlated these findings with the 6-meter walk and the "get-up and go" test results, and compared this to the correlation between patient self-reports and the same objective tests.

"We tell the observers it doesn’t matter how long the person is taking. The important thing is how easy it is for the patient to complete the test or not," explained Dr. Brunton.

A stronger association was found between observer evaluation of walking ability and the timed walk (ANOVA r2 = 0.58; P less than .001) and "get up and go" tests (ANOVA r2= 0.56; P less than .001), than patient self-reports (SF-36; ANOVA r2 = 0.23; P less than .001 and Lequesne ANOVA r2 = 0.27; P less than .001) with the objective tests. ANOVA r2 is a measure of the statistical correlation between the two variables

"It is notable that the observers were watching the patients actually carry out a test whereas patients were asked generally how well they walked," he continued, admitting it was a very different scenario being assessed. "But if you are only asking patients one question on walking you are assuming that their self-assessment and their functional test should be very similar. We have showed this isn’t the case."

The data showed most people did the test with similar times how they rated their own walking ability.

"You can’t just take a questionnaire but you may need to undertake a functional assessment too. Most clinicians would assess patients themselves rather than relying solely on questionnaires. For research, I think we also need a combination of the two methods," he said.

Dr. Brunton has reported no relevant financial disclosures. The meeting was sponsored by the Osteoarthritis Research Society International.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

BOSTON – Just 1% of all surgical procedures are associated with complex surgical site infections, but many develop in association with ill-suited prophylactic antibiotic regimens, according to an analysis of more than 2.4 million American who underwent cardiac or orthopedic surgery during 2006-2009.

Nevertheless, "the vast majority [of surgery patients] don’t get SSIs. Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?" asked Dr. Dale W. Bratzler.

The low overall rate of complex SSIs suggests that any changes to standard SSI prophylaxis regimens should proceed cautiously. "What we need most are strategies for identifying patients at high risk for SSI due to drug-resistant organisms for targeting modified antimicrobial prophylaxis regimens," said Dr. Bratzler, a professor in the department of health administration and policy of the University of Oklahoma, Oklahoma City.

The analysis he reported at the annual meeting of the Infectious Diseases Society of America used data from two large U.S. databases collected from January 2006 to December 2009. Information on the pathogen distribution of SSIs came from the National Healthcare Safety Network database of the Centers for Disease Control and Prevention, which included data from 1,389 U.S. hospitals during this period on the number and type of SSIs that occurred in patients who underwent coronary artery bypass grafting (CABG), and those who had primary total hip or total knee replacement surgery. The second database, from the Hospital Inpatient Quality Reporting Program of the Centers for Medicare and Medicaid Services, collected data on the type of antimicrobial prophylaxis received by patients who underwent these surgical procedures at 3,330 U.S. hospitals.

"Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?"

The National Healthcare Safety Network data showed that a total of 3,024 patients developed a complex SSI among the 207,053 who underwent CABG (1.5%), and 3,532 patients had a complex SSI among the 495,529 patients who had primary hip or knee replacement surgery (0.7%), Dr. Bratzler reported. Complex SSIs were defined as either deep incisional infections, or infections of an organ or surgical space. Among the CABG-associated complex SSIs, 34% were caused by gram-negative bacteria, with the balance caused by gram-positive pathogens, and 17% of all SSIs involved methicillin-resistant Staphylococcus aureus (MRSA). In the arthroplasty patients, 18% of the complex SSIs involved a gram-negative pathogen, and 21% of all infections had MRSA involvement.

The data on type of antibiotic prophylaxis used showed that among 428,541 patients who underwent CABG in this dataset, 67% received "standard" prophylaxis with either cefazolin or cefuroxime; 12% received a regimen designed for patients with beta-lactam allergy with either vancomycin or clindamycin, plus an aminoglycoside added at the provider’s discretion; and 15% had prophylaxis with an extended-spectrum regimen consisting of either vancomycin plus cefazolin or cefuroxime, or an aminoglycoside plus cefazolin or cefuroxime. The remaining 6% of patients received another prophylaxis regimen.

The prophylaxis data for 2,007,162 arthroplasty patients showed that the standard regimen was used in 77%, the beta-lactam allergy regimen in 13%, and the extended-spectrum regimen in 7%, with the remaining 3% of patients receiving something else.

Dr. Bratzler then compared the expected efficacy of the three most commonly used regimens against the pattern of SSIs that actually occurred in these patients. Patients who received the standard regimen could expect protection against about 40% of the types of bacteria that actually wound up producing SSIs. Patients who received the beta-lactam allergy regimens could expect protection against 56%-96% of the pathogens that actually caused the SSIs, and patients who received the extended-spectrum regimens could expect protection against 69%-96%, he said.

The researchers could not do a more detailed analysis of the relationship between the type of prophylaxis used and the pattern of SSIs that subsequently developed because both databases were anonymous, which precluded cross-referencing the information.

Dr. Bratzler said that he had no disclosures.

BOSTON – Just 1% of all surgical procedures are associated with complex surgical site infections, but many develop in association with ill-suited prophylactic antibiotic regimens, according to an analysis of more than 2.4 million American who underwent cardiac or orthopedic surgery during 2006-2009.

Nevertheless, "the vast majority [of surgery patients] don’t get SSIs. Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?" asked Dr. Dale W. Bratzler.

The low overall rate of complex SSIs suggests that any changes to standard SSI prophylaxis regimens should proceed cautiously. "What we need most are strategies for identifying patients at high risk for SSI due to drug-resistant organisms for targeting modified antimicrobial prophylaxis regimens," said Dr. Bratzler, a professor in the department of health administration and policy of the University of Oklahoma, Oklahoma City.

The analysis he reported at the annual meeting of the Infectious Diseases Society of America used data from two large U.S. databases collected from January 2006 to December 2009. Information on the pathogen distribution of SSIs came from the National Healthcare Safety Network database of the Centers for Disease Control and Prevention, which included data from 1,389 U.S. hospitals during this period on the number and type of SSIs that occurred in patients who underwent coronary artery bypass grafting (CABG), and those who had primary total hip or total knee replacement surgery. The second database, from the Hospital Inpatient Quality Reporting Program of the Centers for Medicare and Medicaid Services, collected data on the type of antimicrobial prophylaxis received by patients who underwent these surgical procedures at 3,330 U.S. hospitals.

"Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?"

The National Healthcare Safety Network data showed that a total of 3,024 patients developed a complex SSI among the 207,053 who underwent CABG (1.5%), and 3,532 patients had a complex SSI among the 495,529 patients who had primary hip or knee replacement surgery (0.7%), Dr. Bratzler reported. Complex SSIs were defined as either deep incisional infections, or infections of an organ or surgical space. Among the CABG-associated complex SSIs, 34% were caused by gram-negative bacteria, with the balance caused by gram-positive pathogens, and 17% of all SSIs involved methicillin-resistant Staphylococcus aureus (MRSA). In the arthroplasty patients, 18% of the complex SSIs involved a gram-negative pathogen, and 21% of all infections had MRSA involvement.

The data on type of antibiotic prophylaxis used showed that among 428,541 patients who underwent CABG in this dataset, 67% received "standard" prophylaxis with either cefazolin or cefuroxime; 12% received a regimen designed for patients with beta-lactam allergy with either vancomycin or clindamycin, plus an aminoglycoside added at the provider’s discretion; and 15% had prophylaxis with an extended-spectrum regimen consisting of either vancomycin plus cefazolin or cefuroxime, or an aminoglycoside plus cefazolin or cefuroxime. The remaining 6% of patients received another prophylaxis regimen.

The prophylaxis data for 2,007,162 arthroplasty patients showed that the standard regimen was used in 77%, the beta-lactam allergy regimen in 13%, and the extended-spectrum regimen in 7%, with the remaining 3% of patients receiving something else.

Dr. Bratzler then compared the expected efficacy of the three most commonly used regimens against the pattern of SSIs that actually occurred in these patients. Patients who received the standard regimen could expect protection against about 40% of the types of bacteria that actually wound up producing SSIs. Patients who received the beta-lactam allergy regimens could expect protection against 56%-96% of the pathogens that actually caused the SSIs, and patients who received the extended-spectrum regimens could expect protection against 69%-96%, he said.

The researchers could not do a more detailed analysis of the relationship between the type of prophylaxis used and the pattern of SSIs that subsequently developed because both databases were anonymous, which precluded cross-referencing the information.

Dr. Bratzler said that he had no disclosures.

BOSTON – Just 1% of all surgical procedures are associated with complex surgical site infections, but many develop in association with ill-suited prophylactic antibiotic regimens, according to an analysis of more than 2.4 million American who underwent cardiac or orthopedic surgery during 2006-2009.

Nevertheless, "the vast majority [of surgery patients] don’t get SSIs. Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?" asked Dr. Dale W. Bratzler.

The low overall rate of complex SSIs suggests that any changes to standard SSI prophylaxis regimens should proceed cautiously. "What we need most are strategies for identifying patients at high risk for SSI due to drug-resistant organisms for targeting modified antimicrobial prophylaxis regimens," said Dr. Bratzler, a professor in the department of health administration and policy of the University of Oklahoma, Oklahoma City.

The analysis he reported at the annual meeting of the Infectious Diseases Society of America used data from two large U.S. databases collected from January 2006 to December 2009. Information on the pathogen distribution of SSIs came from the National Healthcare Safety Network database of the Centers for Disease Control and Prevention, which included data from 1,389 U.S. hospitals during this period on the number and type of SSIs that occurred in patients who underwent coronary artery bypass grafting (CABG), and those who had primary total hip or total knee replacement surgery. The second database, from the Hospital Inpatient Quality Reporting Program of the Centers for Medicare and Medicaid Services, collected data on the type of antimicrobial prophylaxis received by patients who underwent these surgical procedures at 3,330 U.S. hospitals.

"Do we want to modify treatment for all patients to address the small proportion who get complex SSIs?"

The National Healthcare Safety Network data showed that a total of 3,024 patients developed a complex SSI among the 207,053 who underwent CABG (1.5%), and 3,532 patients had a complex SSI among the 495,529 patients who had primary hip or knee replacement surgery (0.7%), Dr. Bratzler reported. Complex SSIs were defined as either deep incisional infections, or infections of an organ or surgical space. Among the CABG-associated complex SSIs, 34% were caused by gram-negative bacteria, with the balance caused by gram-positive pathogens, and 17% of all SSIs involved methicillin-resistant Staphylococcus aureus (MRSA). In the arthroplasty patients, 18% of the complex SSIs involved a gram-negative pathogen, and 21% of all infections had MRSA involvement.

The data on type of antibiotic prophylaxis used showed that among 428,541 patients who underwent CABG in this dataset, 67% received "standard" prophylaxis with either cefazolin or cefuroxime; 12% received a regimen designed for patients with beta-lactam allergy with either vancomycin or clindamycin, plus an aminoglycoside added at the provider’s discretion; and 15% had prophylaxis with an extended-spectrum regimen consisting of either vancomycin plus cefazolin or cefuroxime, or an aminoglycoside plus cefazolin or cefuroxime. The remaining 6% of patients received another prophylaxis regimen.

The prophylaxis data for 2,007,162 arthroplasty patients showed that the standard regimen was used in 77%, the beta-lactam allergy regimen in 13%, and the extended-spectrum regimen in 7%, with the remaining 3% of patients receiving something else.

Dr. Bratzler then compared the expected efficacy of the three most commonly used regimens against the pattern of SSIs that actually occurred in these patients. Patients who received the standard regimen could expect protection against about 40% of the types of bacteria that actually wound up producing SSIs. Patients who received the beta-lactam allergy regimens could expect protection against 56%-96% of the pathogens that actually caused the SSIs, and patients who received the extended-spectrum regimens could expect protection against 69%-96%, he said.

The researchers could not do a more detailed analysis of the relationship between the type of prophylaxis used and the pattern of SSIs that subsequently developed because both databases were anonymous, which precluded cross-referencing the information.

Dr. Bratzler said that he had no disclosures.

SAN DIEGO – Even older, heavier, sicker patients, and those with worse mental health, benefit substantially from total hip replacement when indicated, a study has shown.

It’s just that their outcomes aren’t quite as good as those of their younger, leaner, and healthier peers because they also tend to start out with worse preoperative hip pain and function. Even so, they benefit about as much from the operation, gaining in the range of 20 points on the 48-point Oxford Hip Score (OHS), the study found.

Because of that, perhaps physicians should reconsider basing selection of surgery candidates on negative preoperative characteristics; maybe even "patient [body mass index (BMI)] should not be used, as these patients still get substantial improvement following surgery," lead investigator Andy Judge, Ph.D., said at the World Congress on Osteoarthritis, sponsored by Osteoarthritis Research Society International.

The team compared preoperative OHS scores with postoperative scores collected over a 5-year period from 1,375 hip replacement patients who underwent surgery because of osteoarthritis. Each got a cemented Exeter femoral component. Their mean age was 68; 60% were women.

The OHS asks patients 12 multiple-choice questions about pain and function. The five possible answers are scored 0-4, with 0 being the worst possible overall score, and 48 the best.

In general, and regardless of preoperative factors, surgery gave the majority of patients significant relief in the 1st year that was maintained through the 5th year, said Dr. Judge, a senior statistician at the University of Oxford.

There were "small differences in postoperative OHS observed for age, BMI, comorbidity, mental health, and femoral component size, but these patients still received substantial benefit from surgery," he said.

Preoperative hip pain and function was the biggest predictor of how patients fared after the operation. Patients with worse scores tended to have worse postoperative pain and function.

However, even those who entered the operating room with OHS scores below 5 improved, on average, to about 30. Those who entered with scores in the mid-30s improved to the low 40s.

Between-group magnitudes of improvement were similar for other factors taken into account. For instance, average preoperative OHS scores were in the lower teens for those with BMIs at or above 30 kg/m²; postoperative scores were in the mid-30s. Slimmer peers with BMIs below 30 kg/m² entered the operating room with average OHS scores in the upper teens; their postoperative scores improved to about 40 on average.

It was the same story with poorer preoperative mental health scores and higher numbers of comorbidities; patients started and wound up a few points lower on the OHS, but tended to benefit about as much as patients with better mental health and fewer comorbidities.

Patients who were 60-70 years old had the best postoperative scores by a few points, but also started with OHS scores a few points higher than younger and older patients, who, nonetheless, had comparable, roughly 20-point improvements in postoperative OHS scores.

Similarly, patients with larger femoral component sizes (offset of 44 mm or more) also had slightly better outcomes, but also entered the trial with slightly better hip scores. The trial’s findings were statistically significant.

Dr. Judge said he had no relevant financial disclosures. The study was funded by the British National Institute for Health Research.

SAN DIEGO – Even older, heavier, sicker patients, and those with worse mental health, benefit substantially from total hip replacement when indicated, a study has shown.

It’s just that their outcomes aren’t quite as good as those of their younger, leaner, and healthier peers because they also tend to start out with worse preoperative hip pain and function. Even so, they benefit about as much from the operation, gaining in the range of 20 points on the 48-point Oxford Hip Score (OHS), the study found.

Because of that, perhaps physicians should reconsider basing selection of surgery candidates on negative preoperative characteristics; maybe even "patient [body mass index (BMI)] should not be used, as these patients still get substantial improvement following surgery," lead investigator Andy Judge, Ph.D., said at the World Congress on Osteoarthritis, sponsored by Osteoarthritis Research Society International.

The team compared preoperative OHS scores with postoperative scores collected over a 5-year period from 1,375 hip replacement patients who underwent surgery because of osteoarthritis. Each got a cemented Exeter femoral component. Their mean age was 68; 60% were women.

The OHS asks patients 12 multiple-choice questions about pain and function. The five possible answers are scored 0-4, with 0 being the worst possible overall score, and 48 the best.

In general, and regardless of preoperative factors, surgery gave the majority of patients significant relief in the 1st year that was maintained through the 5th year, said Dr. Judge, a senior statistician at the University of Oxford.

There were "small differences in postoperative OHS observed for age, BMI, comorbidity, mental health, and femoral component size, but these patients still received substantial benefit from surgery," he said.

Preoperative hip pain and function was the biggest predictor of how patients fared after the operation. Patients with worse scores tended to have worse postoperative pain and function.

However, even those who entered the operating room with OHS scores below 5 improved, on average, to about 30. Those who entered with scores in the mid-30s improved to the low 40s.

Between-group magnitudes of improvement were similar for other factors taken into account. For instance, average preoperative OHS scores were in the lower teens for those with BMIs at or above 30 kg/m²; postoperative scores were in the mid-30s. Slimmer peers with BMIs below 30 kg/m² entered the operating room with average OHS scores in the upper teens; their postoperative scores improved to about 40 on average.

It was the same story with poorer preoperative mental health scores and higher numbers of comorbidities; patients started and wound up a few points lower on the OHS, but tended to benefit about as much as patients with better mental health and fewer comorbidities.

Patients who were 60-70 years old had the best postoperative scores by a few points, but also started with OHS scores a few points higher than younger and older patients, who, nonetheless, had comparable, roughly 20-point improvements in postoperative OHS scores.

Similarly, patients with larger femoral component sizes (offset of 44 mm or more) also had slightly better outcomes, but also entered the trial with slightly better hip scores. The trial’s findings were statistically significant.

Dr. Judge said he had no relevant financial disclosures. The study was funded by the British National Institute for Health Research.

SAN DIEGO – Even older, heavier, sicker patients, and those with worse mental health, benefit substantially from total hip replacement when indicated, a study has shown.

It’s just that their outcomes aren’t quite as good as those of their younger, leaner, and healthier peers because they also tend to start out with worse preoperative hip pain and function. Even so, they benefit about as much from the operation, gaining in the range of 20 points on the 48-point Oxford Hip Score (OHS), the study found.

Because of that, perhaps physicians should reconsider basing selection of surgery candidates on negative preoperative characteristics; maybe even "patient [body mass index (BMI)] should not be used, as these patients still get substantial improvement following surgery," lead investigator Andy Judge, Ph.D., said at the World Congress on Osteoarthritis, sponsored by Osteoarthritis Research Society International.

The team compared preoperative OHS scores with postoperative scores collected over a 5-year period from 1,375 hip replacement patients who underwent surgery because of osteoarthritis. Each got a cemented Exeter femoral component. Their mean age was 68; 60% were women.

The OHS asks patients 12 multiple-choice questions about pain and function. The five possible answers are scored 0-4, with 0 being the worst possible overall score, and 48 the best.

In general, and regardless of preoperative factors, surgery gave the majority of patients significant relief in the 1st year that was maintained through the 5th year, said Dr. Judge, a senior statistician at the University of Oxford.

There were "small differences in postoperative OHS observed for age, BMI, comorbidity, mental health, and femoral component size, but these patients still received substantial benefit from surgery," he said.

Preoperative hip pain and function was the biggest predictor of how patients fared after the operation. Patients with worse scores tended to have worse postoperative pain and function.

However, even those who entered the operating room with OHS scores below 5 improved, on average, to about 30. Those who entered with scores in the mid-30s improved to the low 40s.

Between-group magnitudes of improvement were similar for other factors taken into account. For instance, average preoperative OHS scores were in the lower teens for those with BMIs at or above 30 kg/m²; postoperative scores were in the mid-30s. Slimmer peers with BMIs below 30 kg/m² entered the operating room with average OHS scores in the upper teens; their postoperative scores improved to about 40 on average.

It was the same story with poorer preoperative mental health scores and higher numbers of comorbidities; patients started and wound up a few points lower on the OHS, but tended to benefit about as much as patients with better mental health and fewer comorbidities.

Patients who were 60-70 years old had the best postoperative scores by a few points, but also started with OHS scores a few points higher than younger and older patients, who, nonetheless, had comparable, roughly 20-point improvements in postoperative OHS scores.

Similarly, patients with larger femoral component sizes (offset of 44 mm or more) also had slightly better outcomes, but also entered the trial with slightly better hip scores. The trial’s findings were statistically significant.

Dr. Judge said he had no relevant financial disclosures. The study was funded by the British National Institute for Health Research.

SAN DIEGO – It’s not unusual for total knee replacement patients to have arthritis in other joints, and it negatively impacts surgery outcomes, Toronto researchers have found.

In their study, 420 of 494 knee replacement patients (85%) reported problems in at least one other joint. Those with foot or ankle arthritis had a significantly reduced chance of achieving an MCID (Minimally Clinically Important Difference) on postoperative WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain and function scores (odds ratio pain 0.32, 95% confidence interval 0.185-0.544; OR function 0.53, 95% CI 0.303, 0.940).

Patients who reported neck problems also had reduced odds of achieving an MCID on physical function WOMAC scores (OR 0.37, 95% CI 0.183, 0.726).

"It’s not surprising that ankles and feet [were] significant. [They] impact activities for which lower-extremity joints are involved. How the upper extremities are associated here, in particular the neck, is unclear," said lead investigator Anthony Perruccio, Ph.D., an epidemiologist and research scientist at the Toronto Western Research Institute.

Because patients with neck problems also saw less improvement in fatigue, anxiety, depression, and pain, there may also be a mental health component, he said.

Whatever the case, the lesson is to treat the whole patient, not just the knee. Referrals to other types of providers are appropriate, including physiotherapists and mental health counselors as needed, said Dr. Perruccio.

"There’s more than just the one joint that’s involved here. Outcomes could be improved if a more holistic approach to osteoarthritis management were considered," he said.

All 494 patients had primary, unilateral knee replacements secondary to osteoarthritis. Their mean age was 65, 65% were women, and almost half were obese.

The patients filled out several surveys before their operations, including WOMAC and other pain and function scales plus the Profile of Mood States (POMS) fatigue scale, the Knee injury and Osteoarthritis Outcome Score (KOOS) sports and recreation scale, and the Hospital Anxiety and Depression Scale (HADS). They also pointed out on a homunculus diagram which joints were causing trouble.

Almost half (46%) reported pain on most days in four or more joints in addition to their operative knee. The nonoperative knee was a problem for 57%, elbows/wrists/hands were problematic for 49%, ankles/feet for 36%, the back for 31%, shoulders for 29%, hips for 25%, and neck for 22%. Just 15% said only their operative knee was symptomatic.

A year after their operation, patients took the surveys again. Those with back problems tended to see less improvement in fatigue at 1 year. Those with ankle or foot arthritis – in addition to diminished returns on pain and function – also saw less improvement than others in depression and sports and recreation scores.

The congress was sponsored by the Osteoarthritis Research Society International. Dr. Perruccio said he had no relevant financial disclosures. The work was funded by the Canadian Institutes of Health Research.

* Correction, 10/21/11: The original headline of this story, "Knee Replacement Worsens Arthritis in Other Joints," misrepresented the findings of this study. The headline has been revised.

SAN DIEGO – It’s not unusual for total knee replacement patients to have arthritis in other joints, and it negatively impacts surgery outcomes, Toronto researchers have found.

In their study, 420 of 494 knee replacement patients (85%) reported problems in at least one other joint. Those with foot or ankle arthritis had a significantly reduced chance of achieving an MCID (Minimally Clinically Important Difference) on postoperative WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain and function scores (odds ratio pain 0.32, 95% confidence interval 0.185-0.544; OR function 0.53, 95% CI 0.303, 0.940).

Patients who reported neck problems also had reduced odds of achieving an MCID on physical function WOMAC scores (OR 0.37, 95% CI 0.183, 0.726).

"It’s not surprising that ankles and feet [were] significant. [They] impact activities for which lower-extremity joints are involved. How the upper extremities are associated here, in particular the neck, is unclear," said lead investigator Anthony Perruccio, Ph.D., an epidemiologist and research scientist at the Toronto Western Research Institute.

Because patients with neck problems also saw less improvement in fatigue, anxiety, depression, and pain, there may also be a mental health component, he said.

Whatever the case, the lesson is to treat the whole patient, not just the knee. Referrals to other types of providers are appropriate, including physiotherapists and mental health counselors as needed, said Dr. Perruccio.

"There’s more than just the one joint that’s involved here. Outcomes could be improved if a more holistic approach to osteoarthritis management were considered," he said.

All 494 patients had primary, unilateral knee replacements secondary to osteoarthritis. Their mean age was 65, 65% were women, and almost half were obese.

The patients filled out several surveys before their operations, including WOMAC and other pain and function scales plus the Profile of Mood States (POMS) fatigue scale, the Knee injury and Osteoarthritis Outcome Score (KOOS) sports and recreation scale, and the Hospital Anxiety and Depression Scale (HADS). They also pointed out on a homunculus diagram which joints were causing trouble.

Almost half (46%) reported pain on most days in four or more joints in addition to their operative knee. The nonoperative knee was a problem for 57%, elbows/wrists/hands were problematic for 49%, ankles/feet for 36%, the back for 31%, shoulders for 29%, hips for 25%, and neck for 22%. Just 15% said only their operative knee was symptomatic.

A year after their operation, patients took the surveys again. Those with back problems tended to see less improvement in fatigue at 1 year. Those with ankle or foot arthritis – in addition to diminished returns on pain and function – also saw less improvement than others in depression and sports and recreation scores.

The congress was sponsored by the Osteoarthritis Research Society International. Dr. Perruccio said he had no relevant financial disclosures. The work was funded by the Canadian Institutes of Health Research.

* Correction, 10/21/11: The original headline of this story, "Knee Replacement Worsens Arthritis in Other Joints," misrepresented the findings of this study. The headline has been revised.

SAN DIEGO – It’s not unusual for total knee replacement patients to have arthritis in other joints, and it negatively impacts surgery outcomes, Toronto researchers have found.

In their study, 420 of 494 knee replacement patients (85%) reported problems in at least one other joint. Those with foot or ankle arthritis had a significantly reduced chance of achieving an MCID (Minimally Clinically Important Difference) on postoperative WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain and function scores (odds ratio pain 0.32, 95% confidence interval 0.185-0.544; OR function 0.53, 95% CI 0.303, 0.940).

Patients who reported neck problems also had reduced odds of achieving an MCID on physical function WOMAC scores (OR 0.37, 95% CI 0.183, 0.726).

"It’s not surprising that ankles and feet [were] significant. [They] impact activities for which lower-extremity joints are involved. How the upper extremities are associated here, in particular the neck, is unclear," said lead investigator Anthony Perruccio, Ph.D., an epidemiologist and research scientist at the Toronto Western Research Institute.

Because patients with neck problems also saw less improvement in fatigue, anxiety, depression, and pain, there may also be a mental health component, he said.

Whatever the case, the lesson is to treat the whole patient, not just the knee. Referrals to other types of providers are appropriate, including physiotherapists and mental health counselors as needed, said Dr. Perruccio.

"There’s more than just the one joint that’s involved here. Outcomes could be improved if a more holistic approach to osteoarthritis management were considered," he said.

All 494 patients had primary, unilateral knee replacements secondary to osteoarthritis. Their mean age was 65, 65% were women, and almost half were obese.

The patients filled out several surveys before their operations, including WOMAC and other pain and function scales plus the Profile of Mood States (POMS) fatigue scale, the Knee injury and Osteoarthritis Outcome Score (KOOS) sports and recreation scale, and the Hospital Anxiety and Depression Scale (HADS). They also pointed out on a homunculus diagram which joints were causing trouble.

Almost half (46%) reported pain on most days in four or more joints in addition to their operative knee. The nonoperative knee was a problem for 57%, elbows/wrists/hands were problematic for 49%, ankles/feet for 36%, the back for 31%, shoulders for 29%, hips for 25%, and neck for 22%. Just 15% said only their operative knee was symptomatic.

A year after their operation, patients took the surveys again. Those with back problems tended to see less improvement in fatigue at 1 year. Those with ankle or foot arthritis – in addition to diminished returns on pain and function – also saw less improvement than others in depression and sports and recreation scores.

The congress was sponsored by the Osteoarthritis Research Society International. Dr. Perruccio said he had no relevant financial disclosures. The work was funded by the Canadian Institutes of Health Research.

* Correction, 10/21/11: The original headline of this story, "Knee Replacement Worsens Arthritis in Other Joints," misrepresented the findings of this study. The headline has been revised.

SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.