Outcomes , such as range of motion , recurrence , and clinical success , were frequently defined , however many different definitions were used .
This systematic review summarizes the outcome reporting st and ards in Dupuytren ’s disease treatment research .
Injectable collagenase clostridium histolyticum for Dupuytren's contracture.
BACKGROUND Dupuytren 's disease limits h and function , diminishes the quality of life , and may ultimately disable the h and . Surgery followed by h and therapy is st and ard treatment , but it is associated with serious potential complications . Injection of collagenase clostridium histolyticum , an office-based , nonsurgical option , may reduce joint contractures caused by Dupuytren 's disease . METHODS We enrolled 308 patients with joint contractures of 20 degrees or more in this prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial . The primary metacarpophalangeal or proximal interphalangeal joints of these patients were r and omly assigned to receive up to three injections of collagenase clostridium histolyticum ( at a dose of 0.58 mg per injection ) or placebo in the contracted collagen cord at 30-day intervals . One day after injection , the joints were manipulated . The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection . Twenty-six secondary end points were evaluated , and data on adverse events were collected . RESULTS Collagenase treatment significantly improved outcomes . More cords that were injected with collagenase than cords injected with placebo met the primary end point ( 64.0 % vs. 6.8 % , P < 0.001 ) , as well as all secondary end points ( P < or = 0.002 ) . Overall , the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo ( from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees , P < 0.001 ) . The most commonly reported adverse events were localized swelling , pain , bruising , pruritus , and transient regional lymph-node enlargement and tenderness . Three treatment-related serious adverse events were reported : two tendon ruptures and one case of complex regional pain syndrome . No significant changes in flexion or grip strength , no systemic allergic reactions , and no nerve injuries were observed . CONCLUSIONS Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren 's disease . ( Clinical Trials.gov number , NCT00528606 .
Outcomes , such as range of motion , recurrence , and clinical success , were frequently defined , however many different definitions were used .
This systematic review summarizes the outcome reporting st and ards in Dupuytren ’s disease treatment research .