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 .
Delayed manipulation after collagenase clostridium histolyticum injection for Dupuytren contracture
Background Collagenase clostridium histolyticum ( CCH ) injection for Dupuytren contracture was approved in the USA in 2010 . Current FDA guidelines stipulate that finger manipulation occurs the day following injection . To investigate the safety and efficacy of delaying manipulation to 2 or 4 days following CCH injection , we conducted a prospect i ve , r and omized trial at two sites . Methods Patients with Dupuytren contracture involving the metacarpophalangeal ( MCP ) joint ≥20 ° caused by a palpable cord participated . All patients received one dose of CCH ( 0.58 mg/0.25 ml ) and were followed for 90 days . The primary end point was the percent of patients maintaining clinical success ( reduction of contracture to 0 ° –5 ° ) at 90 days post-injection . Adverse events and change in Michigan H and Question naire ( MHQ ) score were recorded as secondary end points . Results Thirty-seven patients enrolled ; 13 were manipulated on day 1 , 11 on day 2 , and 13 on day 4 . At 30 days after injection , the percentage of patients obtaining reduction of contracture to < 0 ° –5 ° extension was 92 , 82 , and 85 % in groups 1 , 2 , and 3 , respectively , with no significant difference . At 90 days follow-up , the percentage of patients maintaining 0 ° –5 ° extension was 91 , 82 , and 83 % in groups 1 , 2 , and 3 , respectively , with no significant difference . Adverse events were comparable to rates in prior studies . There were no serious adverse events . There was no statistical difference in MHQ scores between groups at any time point . Conclusions Delaying manipulation to day 2 or 4 following CCH injection for MCP joint contractures does not increase adverse events or result in loss of efficacy . Level of Evidence : Therapeutic , Level II
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 .