The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · Dec 2002
Randomized Controlled Trial Multicenter Study Clinical TrialRecombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients.
The treatment of open fractures of the tibial shaft is often complicated by delayed union and nonunion. The objective of this study was to evaluate the safety and efficacy of the use of recombinant human bone morphogenetic protein-2 (rhBMP-2; dibotermin alfa) to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. ⋯ The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.
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J Bone Joint Surg Am · Nov 2002
Randomized Controlled Trial Multicenter Study Clinical TrialExtracorporeal shock wave therapy in the treatment of lateral epicondylitis : a randomized multicenter trial.
On the basis of observational trials, numerous investigators have recommended extracorporeal shock wave therapy as an alternative treatment for chronic lateral epicondylitis of the elbow. However, there has been no evidence of its efficacy from well-designed randomized clinical trials. The objective of this study was to find out whether extracorporeal shock wave therapy in combination with local anesthesia was superior to placebo therapy in combination with local anesthesia. ⋯ Extracorporeal shock wave therapy as applied in the present study was ineffective in the treatment of lateral epicondylitis. The previously reported success of this therapy appears to be attributable to inappropriate study designs. Different application protocols might improve clinical outcome. We recommend that extracorporeal shock wave therapy be applied only in high-quality clinical trials until it is proved to be effective.
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J Bone Joint Surg Am · Jul 2002
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialSingle-portal endoscopic carpal tunnel release compared with open release : a prospective, randomized trial.
Carpal tunnel syndrome is a common condition causing hand pain and numbness. Endoscopic carpal tunnel release has been demonstrated to reduce recovery time, although previous studies have raised concerns about an increased rate of complications. The purpose of this prospective, randomized study was to compare open carpal tunnel release with single-portal endoscopic carpal tunnel release. ⋯ Good clinical outcomes and patient satisfaction are achieved more quickly when the endoscopic method of carpal tunnel release is used. Single-portal endoscopic surgery is a safe and effective method of treating carpal tunnel syndrome.
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J Bone Joint Surg Am · Dec 2001
Multicenter Study Comparative StudyValidity and responsiveness of the Knee Society Clinical Rating System in comparison with the SF-36 and WOMAC.
The aim of this study was to validate the Knee Society Clinical Rating System (knee and function scores) and to compare its responsiveness with that of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form-36 (SF-36). ⋯ There is a poor correlation among the items of the Knee Society Clinical Rating System, but the rating system has adequate convergent construct validity. The WOMAC and SF-36 are more responsive measures of outcome of total knee arthroplasty. As they are less labor-intensive for researchers to use and as use of these instruments removes observer bias from the study design, they are preferable for knee arthroplasty outcome studies.
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J Bone Joint Surg Am · Jun 2001
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialPrevention of venous thromboembolic disease following primary total knee arthroplasty. A randomized, multicenter, open-label, parallel-group comparison of enoxaparin and warfarin.
Patients treated with total knee arthroplasty are at high risk for the development of venous thromboembolism postoperatively. This study compared the efficacy and safety of two common thromboprophylactic agents, enoxaparin (a low-molecular-weight heparin) and warfarin. ⋯ A fixed 30-mg subcutaneous dose of enoxaparin, administered twice daily, with the first dose administered within eight hours after the completion of surgery, was significantly more effective than adjusted-dose warfarin in reducing the occurrence of asymptomatic venous thromboembolism, including proximal deep-vein thrombosis, in patients undergoing total knee arthroplasty. With the numbers available, there was no significant difference between groups with regard to the occurrence of major hemorrhagic complications; however, the rate of overall hemorrhagic complications was higher in the enoxaparin group.