Orthopedics

Denosumab is approved for the treatment of giant cell tumors of the bone, the Food and Drug Administration announced June 13.

Rare and usually noncancerous, giant cell tumors of the bone generally affect 20- to 40-year-olds. Most of these tumors destroy growing bone, causing pain, limited range of motion, and bone fractures. Rarely, the tumors become cancerous and spread to the lungs.

Denosumab (Xgeva) is indicated for use in patients who are not candidates for surgical resection of their tumors or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should be used only in adolescents whose bones have matured, the FDA said in a statement.

"Today’s approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA reviewed denosumab under its priority review program as the drug was granted orphan product designation because GCTB is a rare disease.

The safety and effectiveness of denosumab for GCTB were established in two clinical trials that enrolled 305 adult or adolescent patients with confirmed GCTB that was recurrent, unresectable, or would be associated with severe morbidity if surgically managed.

After an average of 3 months, tumors reduced in size among 47 of 187 patients whose tumors could be measured. Over an average follow-up of 20 months, GCTBs regrew in three patients whose tumors originally became smaller during treatment.

Common side effects of denosumab included joint pain, headache, nausea, fatigue, back pain, and extremity pain. The most common serious side effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive potential should use highly effective contraception while taking denosumab because of potential fetal harm, according to the FDA.

Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones. It is marketed by Amgen.

[email protected]

On Twitter @maryjodales

Denosumab is approved for the treatment of giant cell tumors of the bone, the Food and Drug Administration announced June 13.

Rare and usually noncancerous, giant cell tumors of the bone generally affect 20- to 40-year-olds. Most of these tumors destroy growing bone, causing pain, limited range of motion, and bone fractures. Rarely, the tumors become cancerous and spread to the lungs.

Denosumab (Xgeva) is indicated for use in patients who are not candidates for surgical resection of their tumors or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should be used only in adolescents whose bones have matured, the FDA said in a statement.

"Today’s approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA reviewed denosumab under its priority review program as the drug was granted orphan product designation because GCTB is a rare disease.

The safety and effectiveness of denosumab for GCTB were established in two clinical trials that enrolled 305 adult or adolescent patients with confirmed GCTB that was recurrent, unresectable, or would be associated with severe morbidity if surgically managed.

After an average of 3 months, tumors reduced in size among 47 of 187 patients whose tumors could be measured. Over an average follow-up of 20 months, GCTBs regrew in three patients whose tumors originally became smaller during treatment.

Common side effects of denosumab included joint pain, headache, nausea, fatigue, back pain, and extremity pain. The most common serious side effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive potential should use highly effective contraception while taking denosumab because of potential fetal harm, according to the FDA.

Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones. It is marketed by Amgen.

[email protected]

On Twitter @maryjodales

Denosumab is approved for the treatment of giant cell tumors of the bone, the Food and Drug Administration announced June 13.

Rare and usually noncancerous, giant cell tumors of the bone generally affect 20- to 40-year-olds. Most of these tumors destroy growing bone, causing pain, limited range of motion, and bone fractures. Rarely, the tumors become cancerous and spread to the lungs.

Denosumab (Xgeva) is indicated for use in patients who are not candidates for surgical resection of their tumors or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should be used only in adolescents whose bones have matured, the FDA said in a statement.

"Today’s approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA reviewed denosumab under its priority review program as the drug was granted orphan product designation because GCTB is a rare disease.

The safety and effectiveness of denosumab for GCTB were established in two clinical trials that enrolled 305 adult or adolescent patients with confirmed GCTB that was recurrent, unresectable, or would be associated with severe morbidity if surgically managed.

After an average of 3 months, tumors reduced in size among 47 of 187 patients whose tumors could be measured. Over an average follow-up of 20 months, GCTBs regrew in three patients whose tumors originally became smaller during treatment.

Common side effects of denosumab included joint pain, headache, nausea, fatigue, back pain, and extremity pain. The most common serious side effects were osteonecrosis of the jaw and osteomyelitis. Women of reproductive potential should use highly effective contraception while taking denosumab because of potential fetal harm, according to the FDA.

Denosumab was approved in 2010 to prevent fractures when cancer has spread to the bones. It is marketed by Amgen.

[email protected]

On Twitter @maryjodales

PHILADELPHIA – Knowledge of a patient’s age, gender, quality of life score, and radiographic knee osteoarthritis severity helps predict the odds of a patient undergoing total knee arthroplasty in the next 5 years.

Few studies have looked at the predictors of total knee arthroplasty (TKA) in community-based cohorts, despite the heavy burden of TKA in the United States, said Dr. Marc C. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore. An estimated 4 million Americans already live with TKA, and more than half of adults diagnosed with knee osteoarthritis (OA) will undergo TKA (J. Bone Joint Surg. Am. 2013;95:385-92).

For the current analysis, Dr. Hochberg and his associates obtained 48 months of annual clinical follow-up data on 6,406 patients in the Osteoarthritis Initiative who had symptomatic, radiographic knee OA or who were at risk for the condition. Follow-up at 60 months involved only questionnaires. Consensus readings of knee radiographs were used for the analysis, along with knee-specific multiple variable regression models. The best models were selected based on Chi-square values and area under the receiver operating characteristic curve (AUC). Radiographic knee OA Kellgren-Lawrence (KL) severity grade 0, 1, 2, 3, and 4 was present in the right knee of 36%, 18%, 28%, 14%, and 3.5% of patients and in the left knee of 38%, 18%, 26%, 14.4%, and 3.3% of patients.

A little more than half of participants were women (58.4%), mean body mass index was 28.7 kg/m², mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was 2.47 (0-20 scale), mean WOMAC function score was 8.33 (0-68 scale), and mean Knee injury and Osteoarthritis Outcome Score (KOOS) (quality of life) was 66.10 (0-100 scale). Their average age was 62.7, he said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

During the 60 months of follow-up, there were 91 right and 102 left TKAs. The AUC for age, sex, and BMI was 0.64 for the right knee and 0.67 for the left knee.

The best TKA prediction models included age, sex, BMI, and KOOS quality-of-life score, improving the AUC to 0.78 for the right knee and 0.80 for the left knee, Dr. Hochberg said. Addition of the WOMAC pain score was associated with a marginal, but significant improvement in the AUC (0.79 and 0.80, respectively). When KL grade was added to these models, the AUC reached 0.89 and 0.91 for the right and left knees, respectively, he said. Sensitivity analyses failed to demonstrate additional effects of other baseline variables when added.

Limitations of the study included the relatively few TKAs, that most patients had KL grade 2 at baseline, proportional hazards analyses were not used, and the study did not consider a correlation between knees or the change in independent variables over time, he said.

In a prospective Canadian study, willingness to undergo surgery was the strongest predictor of the time to first hip or knee total joint replacement (TJR) (Arthritis Rheum. 2006;54:3212-20), while an international OARSI Task Force reported that pain and disability was higher in patients recommended for hip or knee TJR (Osteoarthritis Cartilage 2011;19:147-54). The Task Force, which included Dr. Hochberg, could not, however, identify cut points for pain and disability that would discriminate between those who did or did not get the nod for surgery.

The Osteoarthritis Initiative is sponsored by the National Institutes of Health. Dr. Hochberg reported serving as a consultant for Allergan, Bioiberica, Iroko, Merck, and Pfizer, and as a scientific/medical advisory board member for Eli Lilly and Merck.

[email protected]

PHILADELPHIA – Knowledge of a patient’s age, gender, quality of life score, and radiographic knee osteoarthritis severity helps predict the odds of a patient undergoing total knee arthroplasty in the next 5 years.

Few studies have looked at the predictors of total knee arthroplasty (TKA) in community-based cohorts, despite the heavy burden of TKA in the United States, said Dr. Marc C. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore. An estimated 4 million Americans already live with TKA, and more than half of adults diagnosed with knee osteoarthritis (OA) will undergo TKA (J. Bone Joint Surg. Am. 2013;95:385-92).

For the current analysis, Dr. Hochberg and his associates obtained 48 months of annual clinical follow-up data on 6,406 patients in the Osteoarthritis Initiative who had symptomatic, radiographic knee OA or who were at risk for the condition. Follow-up at 60 months involved only questionnaires. Consensus readings of knee radiographs were used for the analysis, along with knee-specific multiple variable regression models. The best models were selected based on Chi-square values and area under the receiver operating characteristic curve (AUC). Radiographic knee OA Kellgren-Lawrence (KL) severity grade 0, 1, 2, 3, and 4 was present in the right knee of 36%, 18%, 28%, 14%, and 3.5% of patients and in the left knee of 38%, 18%, 26%, 14.4%, and 3.3% of patients.

A little more than half of participants were women (58.4%), mean body mass index was 28.7 kg/m², mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was 2.47 (0-20 scale), mean WOMAC function score was 8.33 (0-68 scale), and mean Knee injury and Osteoarthritis Outcome Score (KOOS) (quality of life) was 66.10 (0-100 scale). Their average age was 62.7, he said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

During the 60 months of follow-up, there were 91 right and 102 left TKAs. The AUC for age, sex, and BMI was 0.64 for the right knee and 0.67 for the left knee.

The best TKA prediction models included age, sex, BMI, and KOOS quality-of-life score, improving the AUC to 0.78 for the right knee and 0.80 for the left knee, Dr. Hochberg said. Addition of the WOMAC pain score was associated with a marginal, but significant improvement in the AUC (0.79 and 0.80, respectively). When KL grade was added to these models, the AUC reached 0.89 and 0.91 for the right and left knees, respectively, he said. Sensitivity analyses failed to demonstrate additional effects of other baseline variables when added.

Limitations of the study included the relatively few TKAs, that most patients had KL grade 2 at baseline, proportional hazards analyses were not used, and the study did not consider a correlation between knees or the change in independent variables over time, he said.

In a prospective Canadian study, willingness to undergo surgery was the strongest predictor of the time to first hip or knee total joint replacement (TJR) (Arthritis Rheum. 2006;54:3212-20), while an international OARSI Task Force reported that pain and disability was higher in patients recommended for hip or knee TJR (Osteoarthritis Cartilage 2011;19:147-54). The Task Force, which included Dr. Hochberg, could not, however, identify cut points for pain and disability that would discriminate between those who did or did not get the nod for surgery.

The Osteoarthritis Initiative is sponsored by the National Institutes of Health. Dr. Hochberg reported serving as a consultant for Allergan, Bioiberica, Iroko, Merck, and Pfizer, and as a scientific/medical advisory board member for Eli Lilly and Merck.

[email protected]

PHILADELPHIA – Knowledge of a patient’s age, gender, quality of life score, and radiographic knee osteoarthritis severity helps predict the odds of a patient undergoing total knee arthroplasty in the next 5 years.

Few studies have looked at the predictors of total knee arthroplasty (TKA) in community-based cohorts, despite the heavy burden of TKA in the United States, said Dr. Marc C. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore. An estimated 4 million Americans already live with TKA, and more than half of adults diagnosed with knee osteoarthritis (OA) will undergo TKA (J. Bone Joint Surg. Am. 2013;95:385-92).

For the current analysis, Dr. Hochberg and his associates obtained 48 months of annual clinical follow-up data on 6,406 patients in the Osteoarthritis Initiative who had symptomatic, radiographic knee OA or who were at risk for the condition. Follow-up at 60 months involved only questionnaires. Consensus readings of knee radiographs were used for the analysis, along with knee-specific multiple variable regression models. The best models were selected based on Chi-square values and area under the receiver operating characteristic curve (AUC). Radiographic knee OA Kellgren-Lawrence (KL) severity grade 0, 1, 2, 3, and 4 was present in the right knee of 36%, 18%, 28%, 14%, and 3.5% of patients and in the left knee of 38%, 18%, 26%, 14.4%, and 3.3% of patients.

A little more than half of participants were women (58.4%), mean body mass index was 28.7 kg/m², mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was 2.47 (0-20 scale), mean WOMAC function score was 8.33 (0-68 scale), and mean Knee injury and Osteoarthritis Outcome Score (KOOS) (quality of life) was 66.10 (0-100 scale). Their average age was 62.7, he said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

During the 60 months of follow-up, there were 91 right and 102 left TKAs. The AUC for age, sex, and BMI was 0.64 for the right knee and 0.67 for the left knee.

The best TKA prediction models included age, sex, BMI, and KOOS quality-of-life score, improving the AUC to 0.78 for the right knee and 0.80 for the left knee, Dr. Hochberg said. Addition of the WOMAC pain score was associated with a marginal, but significant improvement in the AUC (0.79 and 0.80, respectively). When KL grade was added to these models, the AUC reached 0.89 and 0.91 for the right and left knees, respectively, he said. Sensitivity analyses failed to demonstrate additional effects of other baseline variables when added.

Limitations of the study included the relatively few TKAs, that most patients had KL grade 2 at baseline, proportional hazards analyses were not used, and the study did not consider a correlation between knees or the change in independent variables over time, he said.

In a prospective Canadian study, willingness to undergo surgery was the strongest predictor of the time to first hip or knee total joint replacement (TJR) (Arthritis Rheum. 2006;54:3212-20), while an international OARSI Task Force reported that pain and disability was higher in patients recommended for hip or knee TJR (Osteoarthritis Cartilage 2011;19:147-54). The Task Force, which included Dr. Hochberg, could not, however, identify cut points for pain and disability that would discriminate between those who did or did not get the nod for surgery.

The Osteoarthritis Initiative is sponsored by the National Institutes of Health. Dr. Hochberg reported serving as a consultant for Allergan, Bioiberica, Iroko, Merck, and Pfizer, and as a scientific/medical advisory board member for Eli Lilly and Merck.

[email protected]

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

Aspirin is an effective, safe, convenient, and inexpensive alternative to low-molecular-weight heparin for extended thromboprophylaxis after total hip arthroplasty, according to a report published online June 3 in Annals of Internal Medicine.

In a multicenter randomized trial involving 786 patients undergoing elective total hip replacement in Canada during a 3-year period, 28 days of oral aspirin prophylaxis was noninferior to and as safe as 28 days of subcutaneous dalteparin injections for preventing venous thromboembolism (VTE), according to Dr. David R. Anderson, who is professor of medicine, pathology, and community health and epidemiology of Dalhousie University, Halifax, N.S., and his associates in the EPCAT (Extended Prophylaxis Comparing Low-Molecular-Weight Heparin to Aspirin in Total Hip Arthroplasty) study.

During this trial, the novel oral anticoagulant rivaroxaban was approved for this indication in Canada, which prompted "a major shift" away from using dalteparin and toward using the new drug in clinical practice. In light of this development, it will be important to "evaluate the benefits and risks of aspirin as extended prophylaxis after [total hip replacement], compared with the new oral anticoagulant agents," noted the EPCAT investigators.

Their findings on the benefits of aspirin also indicate that its role for venous thromboprophylaxis in other settings should now be reconsidered as well, Dr. Anderson and his colleagues added.

In the EPCAT study, patients underwent elective unilateral total hip replacement at 12 university-affiliated tertiary medical centers and received thromboprophylaxis in the form of subcutaneous injections of dalteparin for 10 days. They were randomly assigned to continue receiving dalteparin injections and take placebo oral aspirin tablets (400 patients) or to receive placebo injections and begin taking oral aspirin (81 mg) every day for 28 days (386 patients).

The demographic, medical, and surgical characteristics of the two study groups were comparable. Patients, physicians, study coordinators, and members of the health care teams all were blinded to study assignment.

The introduction of rivaroxaban during the course of the study severely affected ongoing recruitment of subjects, because both patients and orthopedic surgeons became increasingly reluctant to participate in a study requiring daily injections for 38 days when a new oral agent was available. The EPCAT study was terminated early when completion of the intended enrollment appeared "unfeasible" and an interim analysis showed that the primary objective – establishing the noninferiority of aspirin – had been reached.

The primary efficacy outcome was the development of symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE), confirmed by objective testing, during the 90 days after randomization. This outcome occurred in only 0.3% of the aspirin group, compared with 1.3% of the dalteparin group, establishing the noninferiority of aspirin therapy.

There was a single case of proximal DVT in the aspirin group, compared with two cases of proximal DVT and three of PE in the dalteparin group. Another patient in the dalteparin group developed a symptomatic distal DVT in her calf, "but this was not considered an outcome event," the investigators said.

No major bleeding events developed in the aspirin group, but there was one such event in the dalteparin group for an overall rate of 0.3%. Similarly, there were two clinically significant nonmajor bleeding events for aspirin (0.5% rate), compared with four for dalteparin (1.0% rate). And there were eight minor bleeding events for aspirin (2.1% rate), compared with 18 for dalteparin (4.5% rate).

"In a composite analysis of net clinical benefit that combined VTE and clinically relevant major and nonmajor bleeding complications as outcomes," 0.8% of patients receiving aspirin had complications, compared with 2.5% of patients receiving dalteparin.

There were no differences between the two study groups in secondary outcomes such as wound infections, arterial vascular events, MI, stroke, or deaths.

The EPCAT trial was supported by the Canadian Institutes for Health Research. Aspirin was provided by Bayer HealthCare and dalteparin by Pfizer Pharmaceuticals, but neither Bayer nor Pfizer was involved in the design, conduct, or analysis of the study.

ILLUSTRATIVE CASE

A 60-year-old assembly line worker reports bilateral hand numbness and tingling that frequently awaken her at night. What is the best office test to determine if she has CTS?

CTS is one of the most common causes of disability in the United States.² Among patients with hand paresthesias, one in five has CTS.² Factory workers whose jobs involve repetitive hand movements, women, and the elderly are at increased risk.³ If left untreated, the symptoms are likely to become constant, with thenar muscle wasting and weakness.

Traditional diagnostic test 
has only 50% sensitivity
In the traditional Phalen’s test (TPT)—commonly used in an office setting—the patient holds his or her wrists in a position of fixed flexion for one minute. The onset of paresthesias is considered a positive result.

The TPT was found in the study reported here to be 100% specific;¹ however, other studies have found a wider range of specificity (33% to 86%).⁴ The TPT has a sensitivity of only 50%, which increases the risk that cases of CTS will be missed. This is an important consideration, because establishing a diagnosis early in the course of CTS has been shown to minimize disability.⁵

STUDY SUMMARY
Modified Phalen’s has higher sensitivity
Bilkis et al developed a modified Phalen’s test and compared it with the TPT, as well as with electrodiagnostic studies (EDS)—the gold standard for CTS diagnosis. The MPT begins with the TPT position and adds sensory testing with a Semmes-Weinstein 2.83-unit monofilament.

See how the modified Phalen’s test is done

The filament is applied perpendicular to the palmar and lateral surface of each distal finger three times, with enough pressure to bend the monofilament. In this study, the test was considered “positive” if the patient did not feel the monofilament in any finger along the distribution of the median nerve. The MPT was “negative” if the patient correctly reported being touched along this distribution. The fifth, or “pinkie,” finger, which is less likely to be affected by CTS, was used as a control.

Participants in the study were adult patients—mostly women between the ages of 27 and 88—at a neurology clinic. Exclusion criteria included cervical radiculopathy, a history of stroke, diabetes, and concomitant neck injury. A total of 66 hands (and 37 participants) underwent TPT and MPT testing by trained examiners, followed by EDS to confirm the findings.

EDS found evidence of CTS in 46 of the 66 hands studied. The MPT correctly identified 39 of the 46, while the TPT correctly identified 23. Both the traditional and the modified Phalen’s tests were found to be 100% specific, but the sensitivity of the MPT was 85% (95% confidence interval [CI], 71% to 93%), compared with 50% (95% CI, 35% to 65%) for the TPT.

WHAT’S NEW
Better results can be achieved in seconds
The addition of monofilament testing to the TPT increases the sensitivity in identifying CTS. The MPT is simple to learn and, based on our observations, adds only about 10 to 15 seconds to the clinical exam.

CAVEATS
Modification is untested in primary care
A diagnosis of CTS is rarely made on the basis of one test, but rather on a set of signs, symptoms, and physical exam maneuvers. The added value of the MPT needs to be evaluated in the larger context of the comprehensive clinical examination for CTS.⁶

Notably, the study participants were seen in a neurology clinic, which suggests that they may have had more advanced CTS than typical primary care patients. That would help explain the 100% specificity of both the traditional and modified tests reported by the researchers. The sensitivity of the MPT may therefore be lower in a family practice because the spectrum of disease may be wider. Another study is needed to evaluate the performance of the MPT in a primary care setting.

The monofilament used (Semmes-Weinstein 2.83) is not the same as the typical 5.07 (10-g) monofilament used in diabetic foot screenings. Using this heavier monofilament with a stronger pressure point would likely decrease the sensitivity of the MPT.

CHALLENGES TO IMPLEMENTATION
Taking the time, obtaining the monofilament
Additional time to obtain the correct monofilament and administer the MPT are the key challenges to implementation.

REFERENCES
1. Bilkis S, Loveman DM, Eldridge JA, et al. Modified Phalen’s test as an aid in diagnosing carpal tunnel syndrome. Arthritis Care Res. 2012;64:287-289.

2. Atroshi I, Gummesson C, Johnsson R, et al. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999;282:153-158.

3. National Institute of Neurological Disorders and Stroke. Carpal tunnel syndrome fact sheet. National Institutes of Health. July 2012. www.ninds.nih.gov/disorders/carpal_tunnel/detail_carpal_tunnel.htm. Accessed April 15, 2013.

4. McGee SR. Evidence-Based Physical Diagnosis. 3rd ed. Philadelphia, PA: Saunders; 2012:chap 62.

5. Daniell WE, Fulton-Kehoe D, Franklin GM. Work-related carpal tunnel syndrome in Washington State workers’ compensation: utilization of surgery and the duration of lost work. Am J Ind Med. 2009;52:931-942.

6. D’Arcy CA, McGee S. Does this patient have carpal tunnel syndrome? JAMA. 2000;282:3110-3117.

ACKNOWLEDGEMENT
The PURLs Surveillance System was developed with support from Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(5):253-254.

ILLUSTRATIVE CASE

A 60-year-old assembly line worker reports bilateral hand numbness and tingling that frequently awaken her at night. What is the best office test to determine if she has CTS?

CTS is one of the most common causes of disability in the United States.² Among patients with hand paresthesias, one in five has CTS.² Factory workers whose jobs involve repetitive hand movements, women, and the elderly are at increased risk.³ If left untreated, the symptoms are likely to become constant, with thenar muscle wasting and weakness.

Traditional diagnostic test 
has only 50% sensitivity
In the traditional Phalen’s test (TPT)—commonly used in an office setting—the patient holds his or her wrists in a position of fixed flexion for one minute. The onset of paresthesias is considered a positive result.

The TPT was found in the study reported here to be 100% specific;¹ however, other studies have found a wider range of specificity (33% to 86%).⁴ The TPT has a sensitivity of only 50%, which increases the risk that cases of CTS will be missed. This is an important consideration, because establishing a diagnosis early in the course of CTS has been shown to minimize disability.⁵

STUDY SUMMARY
Modified Phalen’s has higher sensitivity
Bilkis et al developed a modified Phalen’s test and compared it with the TPT, as well as with electrodiagnostic studies (EDS)—the gold standard for CTS diagnosis. The MPT begins with the TPT position and adds sensory testing with a Semmes-Weinstein 2.83-unit monofilament.

See how the modified Phalen’s test is done

The filament is applied perpendicular to the palmar and lateral surface of each distal finger three times, with enough pressure to bend the monofilament. In this study, the test was considered “positive” if the patient did not feel the monofilament in any finger along the distribution of the median nerve. The MPT was “negative” if the patient correctly reported being touched along this distribution. The fifth, or “pinkie,” finger, which is less likely to be affected by CTS, was used as a control.

Participants in the study were adult patients—mostly women between the ages of 27 and 88—at a neurology clinic. Exclusion criteria included cervical radiculopathy, a history of stroke, diabetes, and concomitant neck injury. A total of 66 hands (and 37 participants) underwent TPT and MPT testing by trained examiners, followed by EDS to confirm the findings.

EDS found evidence of CTS in 46 of the 66 hands studied. The MPT correctly identified 39 of the 46, while the TPT correctly identified 23. Both the traditional and the modified Phalen’s tests were found to be 100% specific, but the sensitivity of the MPT was 85% (95% confidence interval [CI], 71% to 93%), compared with 50% (95% CI, 35% to 65%) for the TPT.

WHAT’S NEW
Better results can be achieved in seconds
The addition of monofilament testing to the TPT increases the sensitivity in identifying CTS. The MPT is simple to learn and, based on our observations, adds only about 10 to 15 seconds to the clinical exam.

CAVEATS
Modification is untested in primary care
A diagnosis of CTS is rarely made on the basis of one test, but rather on a set of signs, symptoms, and physical exam maneuvers. The added value of the MPT needs to be evaluated in the larger context of the comprehensive clinical examination for CTS.⁶

Notably, the study participants were seen in a neurology clinic, which suggests that they may have had more advanced CTS than typical primary care patients. That would help explain the 100% specificity of both the traditional and modified tests reported by the researchers. The sensitivity of the MPT may therefore be lower in a family practice because the spectrum of disease may be wider. Another study is needed to evaluate the performance of the MPT in a primary care setting.

The monofilament used (Semmes-Weinstein 2.83) is not the same as the typical 5.07 (10-g) monofilament used in diabetic foot screenings. Using this heavier monofilament with a stronger pressure point would likely decrease the sensitivity of the MPT.

CHALLENGES TO IMPLEMENTATION
Taking the time, obtaining the monofilament
Additional time to obtain the correct monofilament and administer the MPT are the key challenges to implementation.

REFERENCES
1. Bilkis S, Loveman DM, Eldridge JA, et al. Modified Phalen’s test as an aid in diagnosing carpal tunnel syndrome. Arthritis Care Res. 2012;64:287-289.

2. Atroshi I, Gummesson C, Johnsson R, et al. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999;282:153-158.

3. National Institute of Neurological Disorders and Stroke. Carpal tunnel syndrome fact sheet. National Institutes of Health. July 2012. www.ninds.nih.gov/disorders/carpal_tunnel/detail_carpal_tunnel.htm. Accessed April 15, 2013.

4. McGee SR. Evidence-Based Physical Diagnosis. 3rd ed. Philadelphia, PA: Saunders; 2012:chap 62.

5. Daniell WE, Fulton-Kehoe D, Franklin GM. Work-related carpal tunnel syndrome in Washington State workers’ compensation: utilization of surgery and the duration of lost work. Am J Ind Med. 2009;52:931-942.

6. D’Arcy CA, McGee S. Does this patient have carpal tunnel syndrome? JAMA. 2000;282:3110-3117.

ACKNOWLEDGEMENT
The PURLs Surveillance System was developed with support from Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(5):253-254.

ILLUSTRATIVE CASE

A 60-year-old assembly line worker reports bilateral hand numbness and tingling that frequently awaken her at night. What is the best office test to determine if she has CTS?

CTS is one of the most common causes of disability in the United States.² Among patients with hand paresthesias, one in five has CTS.² Factory workers whose jobs involve repetitive hand movements, women, and the elderly are at increased risk.³ If left untreated, the symptoms are likely to become constant, with thenar muscle wasting and weakness.

Traditional diagnostic test 
has only 50% sensitivity
In the traditional Phalen’s test (TPT)—commonly used in an office setting—the patient holds his or her wrists in a position of fixed flexion for one minute. The onset of paresthesias is considered a positive result.

The TPT was found in the study reported here to be 100% specific;¹ however, other studies have found a wider range of specificity (33% to 86%).⁴ The TPT has a sensitivity of only 50%, which increases the risk that cases of CTS will be missed. This is an important consideration, because establishing a diagnosis early in the course of CTS has been shown to minimize disability.⁵

STUDY SUMMARY
Modified Phalen’s has higher sensitivity
Bilkis et al developed a modified Phalen’s test and compared it with the TPT, as well as with electrodiagnostic studies (EDS)—the gold standard for CTS diagnosis. The MPT begins with the TPT position and adds sensory testing with a Semmes-Weinstein 2.83-unit monofilament.

See how the modified Phalen’s test is done

The filament is applied perpendicular to the palmar and lateral surface of each distal finger three times, with enough pressure to bend the monofilament. In this study, the test was considered “positive” if the patient did not feel the monofilament in any finger along the distribution of the median nerve. The MPT was “negative” if the patient correctly reported being touched along this distribution. The fifth, or “pinkie,” finger, which is less likely to be affected by CTS, was used as a control.

Participants in the study were adult patients—mostly women between the ages of 27 and 88—at a neurology clinic. Exclusion criteria included cervical radiculopathy, a history of stroke, diabetes, and concomitant neck injury. A total of 66 hands (and 37 participants) underwent TPT and MPT testing by trained examiners, followed by EDS to confirm the findings.

EDS found evidence of CTS in 46 of the 66 hands studied. The MPT correctly identified 39 of the 46, while the TPT correctly identified 23. Both the traditional and the modified Phalen’s tests were found to be 100% specific, but the sensitivity of the MPT was 85% (95% confidence interval [CI], 71% to 93%), compared with 50% (95% CI, 35% to 65%) for the TPT.

WHAT’S NEW
Better results can be achieved in seconds
The addition of monofilament testing to the TPT increases the sensitivity in identifying CTS. The MPT is simple to learn and, based on our observations, adds only about 10 to 15 seconds to the clinical exam.

CAVEATS
Modification is untested in primary care
A diagnosis of CTS is rarely made on the basis of one test, but rather on a set of signs, symptoms, and physical exam maneuvers. The added value of the MPT needs to be evaluated in the larger context of the comprehensive clinical examination for CTS.⁶

Notably, the study participants were seen in a neurology clinic, which suggests that they may have had more advanced CTS than typical primary care patients. That would help explain the 100% specificity of both the traditional and modified tests reported by the researchers. The sensitivity of the MPT may therefore be lower in a family practice because the spectrum of disease may be wider. Another study is needed to evaluate the performance of the MPT in a primary care setting.

The monofilament used (Semmes-Weinstein 2.83) is not the same as the typical 5.07 (10-g) monofilament used in diabetic foot screenings. Using this heavier monofilament with a stronger pressure point would likely decrease the sensitivity of the MPT.

CHALLENGES TO IMPLEMENTATION
Taking the time, obtaining the monofilament
Additional time to obtain the correct monofilament and administer the MPT are the key challenges to implementation.

REFERENCES
1. Bilkis S, Loveman DM, Eldridge JA, et al. Modified Phalen’s test as an aid in diagnosing carpal tunnel syndrome. Arthritis Care Res. 2012;64:287-289.

2. Atroshi I, Gummesson C, Johnsson R, et al. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999;282:153-158.

3. National Institute of Neurological Disorders and Stroke. Carpal tunnel syndrome fact sheet. National Institutes of Health. July 2012. www.ninds.nih.gov/disorders/carpal_tunnel/detail_carpal_tunnel.htm. Accessed April 15, 2013.

4. McGee SR. Evidence-Based Physical Diagnosis. 3rd ed. Philadelphia, PA: Saunders; 2012:chap 62.

5. Daniell WE, Fulton-Kehoe D, Franklin GM. Work-related carpal tunnel syndrome in Washington State workers’ compensation: utilization of surgery and the duration of lost work. Am J Ind Med. 2009;52:931-942.

6. D’Arcy CA, McGee S. Does this patient have carpal tunnel syndrome? JAMA. 2000;282:3110-3117.

ACKNOWLEDGEMENT
The PURLs Surveillance System was developed with support from Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Copyright © 2013. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice. 2013;62(5):253-254.

BIRMINGHAM, ENGLAND – Contrary to expectations, metal-on-metal hip resurfacing for osteoarthritis was associated with higher patient survival at 10 years than was total hip arthroplasty in a large, population-based study.

Cumulative mortality rates were 2.8% for hip resurfacing versus 7.3% for cemented total hip replacement (THR; hazard ratio, 0.51). Ten-year mortality rates comparing hip resurfacing to uncemented THR were 2.6% and 3.2%, respectively (HR, 0.64).

Furthermore, the number needed to treat with hip resurfacing to prevent 1 excess death was 29 when compared to cemented THR, and it was 88 when compared to uncemented THR.

"Patients who received a metal-on-metal resurfacing [MoMR] procedure seem to have a long-term survival advantage compared to patients receiving cemented or an uncemented THR," said Dr. Adrian Kendal of the National Institute for Health Research (NIHR) Musculoskeletal Biomedical Research Unit at the University of Oxford, England.

"Our findings were robust after adjustment for known confounders," Dr. Kendal said at the British Society for Rheumatology annual conference. Propensity matching was used in the trial, which took age, gender, comorbidity, rurality, and social deprivation into account.

For the study, data from the English Hospital Episode Statistics database were obtained and linked to Office for National Statistics mortality records for all adults (over age 18) undergoing elective primary hip replacement for osteoarthritis in National Health Service hospitals in England and Wales between April 1999 and March 2012.

After propensity score matching, there were 91,633 procedures performed, of which 12,580 were MoMR, 37,740 were cemented THR, and 41,312 were uncemented THR.

In response to a comment that perhaps people opting for MoMR were more likely to be younger, more active, and hence more likely to exercise, Dr. Kendal conceded that other factors might exist that could have affected survival.

Speculating about why there might be such a difference in survival, he said: "I personally don’t think it’s just the use of cement, because that doesn’t explain the group that received an uncemented total hip replacement."

He added that the way the femur is prepared during THR might be important, regardless of whether or not cement is used. The known risk of thrombotic consequences also could affect survival. In addition, health care inequality might be important, as resurfacing procedures are less common than THR, perhaps because of the lack of specialized centers or dedicated teams.

Commenting on the findings after their presentation, consultant rheumatologist Dr. Alex MacGregor, of the University of East Anglia, Norwich, England, noted that similar data were published on this topic last year (BMJ 2012;344:e3319), but the results had proved somewhat controversial as the authors had a conflict of interest in favor of hip resurfacing.

Dr. MacGregor, who is a member of the National Joint Registry Steering Committee, has been involved in a subsequent reanalysis of the paper’s findings and said that the results will be made public later in the year.

"One of my concerns [with this study] is the use of the 10-year mortality endpoint. If these resurfacing procedures are saving lives, then you would expect to see a survival benefit sooner, say at 90 days," Dr. MacGregor said.

Dr. Kendal responded that they tried to account for this, but the answer will need to come from a properly organized, randomized controlled trial.

"We don’t have a conflict of interest here. If anything, we were perhaps looking for the opposite effect; we were expecting to see an increased mortality rate in the resurfacing group," Dr. Kendal said. "That was not the case as it turned out, so I am reasonably confident that our data support the findings of that BMJ article."

Dr. Kendal and Dr. MacGregor reported no conflicts of interest.

[email protected]

BIRMINGHAM, ENGLAND – Contrary to expectations, metal-on-metal hip resurfacing for osteoarthritis was associated with higher patient survival at 10 years than was total hip arthroplasty in a large, population-based study.

Cumulative mortality rates were 2.8% for hip resurfacing versus 7.3% for cemented total hip replacement (THR; hazard ratio, 0.51). Ten-year mortality rates comparing hip resurfacing to uncemented THR were 2.6% and 3.2%, respectively (HR, 0.64).

Furthermore, the number needed to treat with hip resurfacing to prevent 1 excess death was 29 when compared to cemented THR, and it was 88 when compared to uncemented THR.

"Patients who received a metal-on-metal resurfacing [MoMR] procedure seem to have a long-term survival advantage compared to patients receiving cemented or an uncemented THR," said Dr. Adrian Kendal of the National Institute for Health Research (NIHR) Musculoskeletal Biomedical Research Unit at the University of Oxford, England.

"Our findings were robust after adjustment for known confounders," Dr. Kendal said at the British Society for Rheumatology annual conference. Propensity matching was used in the trial, which took age, gender, comorbidity, rurality, and social deprivation into account.

For the study, data from the English Hospital Episode Statistics database were obtained and linked to Office for National Statistics mortality records for all adults (over age 18) undergoing elective primary hip replacement for osteoarthritis in National Health Service hospitals in England and Wales between April 1999 and March 2012.

After propensity score matching, there were 91,633 procedures performed, of which 12,580 were MoMR, 37,740 were cemented THR, and 41,312 were uncemented THR.

In response to a comment that perhaps people opting for MoMR were more likely to be younger, more active, and hence more likely to exercise, Dr. Kendal conceded that other factors might exist that could have affected survival.

Speculating about why there might be such a difference in survival, he said: "I personally don’t think it’s just the use of cement, because that doesn’t explain the group that received an uncemented total hip replacement."

He added that the way the femur is prepared during THR might be important, regardless of whether or not cement is used. The known risk of thrombotic consequences also could affect survival. In addition, health care inequality might be important, as resurfacing procedures are less common than THR, perhaps because of the lack of specialized centers or dedicated teams.

Commenting on the findings after their presentation, consultant rheumatologist Dr. Alex MacGregor, of the University of East Anglia, Norwich, England, noted that similar data were published on this topic last year (BMJ 2012;344:e3319), but the results had proved somewhat controversial as the authors had a conflict of interest in favor of hip resurfacing.

Dr. MacGregor, who is a member of the National Joint Registry Steering Committee, has been involved in a subsequent reanalysis of the paper’s findings and said that the results will be made public later in the year.

"One of my concerns [with this study] is the use of the 10-year mortality endpoint. If these resurfacing procedures are saving lives, then you would expect to see a survival benefit sooner, say at 90 days," Dr. MacGregor said.

Dr. Kendal responded that they tried to account for this, but the answer will need to come from a properly organized, randomized controlled trial.

"We don’t have a conflict of interest here. If anything, we were perhaps looking for the opposite effect; we were expecting to see an increased mortality rate in the resurfacing group," Dr. Kendal said. "That was not the case as it turned out, so I am reasonably confident that our data support the findings of that BMJ article."

Dr. Kendal and Dr. MacGregor reported no conflicts of interest.

[email protected]

BIRMINGHAM, ENGLAND – Contrary to expectations, metal-on-metal hip resurfacing for osteoarthritis was associated with higher patient survival at 10 years than was total hip arthroplasty in a large, population-based study.

Cumulative mortality rates were 2.8% for hip resurfacing versus 7.3% for cemented total hip replacement (THR; hazard ratio, 0.51). Ten-year mortality rates comparing hip resurfacing to uncemented THR were 2.6% and 3.2%, respectively (HR, 0.64).

Furthermore, the number needed to treat with hip resurfacing to prevent 1 excess death was 29 when compared to cemented THR, and it was 88 when compared to uncemented THR.

"Patients who received a metal-on-metal resurfacing [MoMR] procedure seem to have a long-term survival advantage compared to patients receiving cemented or an uncemented THR," said Dr. Adrian Kendal of the National Institute for Health Research (NIHR) Musculoskeletal Biomedical Research Unit at the University of Oxford, England.

"Our findings were robust after adjustment for known confounders," Dr. Kendal said at the British Society for Rheumatology annual conference. Propensity matching was used in the trial, which took age, gender, comorbidity, rurality, and social deprivation into account.

For the study, data from the English Hospital Episode Statistics database were obtained and linked to Office for National Statistics mortality records for all adults (over age 18) undergoing elective primary hip replacement for osteoarthritis in National Health Service hospitals in England and Wales between April 1999 and March 2012.

After propensity score matching, there were 91,633 procedures performed, of which 12,580 were MoMR, 37,740 were cemented THR, and 41,312 were uncemented THR.

In response to a comment that perhaps people opting for MoMR were more likely to be younger, more active, and hence more likely to exercise, Dr. Kendal conceded that other factors might exist that could have affected survival.

Speculating about why there might be such a difference in survival, he said: "I personally don’t think it’s just the use of cement, because that doesn’t explain the group that received an uncemented total hip replacement."

He added that the way the femur is prepared during THR might be important, regardless of whether or not cement is used. The known risk of thrombotic consequences also could affect survival. In addition, health care inequality might be important, as resurfacing procedures are less common than THR, perhaps because of the lack of specialized centers or dedicated teams.

Commenting on the findings after their presentation, consultant rheumatologist Dr. Alex MacGregor, of the University of East Anglia, Norwich, England, noted that similar data were published on this topic last year (BMJ 2012;344:e3319), but the results had proved somewhat controversial as the authors had a conflict of interest in favor of hip resurfacing.

Dr. MacGregor, who is a member of the National Joint Registry Steering Committee, has been involved in a subsequent reanalysis of the paper’s findings and said that the results will be made public later in the year.

"One of my concerns [with this study] is the use of the 10-year mortality endpoint. If these resurfacing procedures are saving lives, then you would expect to see a survival benefit sooner, say at 90 days," Dr. MacGregor said.

Dr. Kendal responded that they tried to account for this, but the answer will need to come from a properly organized, randomized controlled trial.

"We don’t have a conflict of interest here. If anything, we were perhaps looking for the opposite effect; we were expecting to see an increased mortality rate in the resurfacing group," Dr. Kendal said. "That was not the case as it turned out, so I am reasonably confident that our data support the findings of that BMJ article."

Dr. Kendal and Dr. MacGregor reported no conflicts of interest.

[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]

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.

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