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: a new nonsurgical treatment for Dupuytren's disease.
PURPOSE The Collagenase Option for the Reduction of Dupuytren 's ( CORD ) II study investigated the efficacy and safety of injectable Xiaflex ( collagenase clostridium histolyticum ) , in patients with Dupuytren 's contracture . METHODS This was a prospect i ve , r and omized , placebo-controlled trial with 90-day double-blind and 9-month open-label phases . We r and omized patients with contractures affecting metacarpophalangeal ( MCP ) or proximal interphalangeal ( PIP ) joints 2 to 1 to collagenase ( 0.58 mg ) or placebo . Cords received a maximum of 3 injections . Cord disruption was attempted the day after injection using a st and ardized finger extension procedure . Primary end point was reduction in contracture to 0 ° to 5 ° of normal 30 days after the last injection . RESULTS We enrolled 66 patients ; 45 cords ( 20 MCP to 25 PIP joints )  received collagenase and 21 cords ( 11 MCP to 10 PIP joints ) received placebo in the double-blind phase . Statistically significantly more cords injected with collagenase than placebo met the primary end point ( 44.4 % vs 4.8 % ; p < . 001 ) . The mean percentage decrease in degree of joint contracture from baseline to 30 days after last injection was 70.5 % ± 29.2 % in the collagenase group and 13.6 % ± 26.1 % in the placebo group ( p < .001 ) . The mean increase in range of motion was significantly greater in the collagenase ( 35.4 ° ± 17.8 ° ) than in the placebo ( 7.6 ° ± 14.9 ° ; p < .001 ) group . Efficacy after open-label treatment was similar to that after the double-blind phase : 50.7 % of all joints achieved 0 ° to 5 ° of normal . More patients were satisfied with collagenase ( p < .001 ) . No joint had recurrence of contracture . One patient had a flexion pulley rupture and one patient underwent routine fasciectomy to address cord proliferation and sensory abnormality . No tendon ruptures or systemic allergic reactions were reported . Most adverse events were related to the injection or finger extension procedure . CONCLUSIONS Collagenase clostridium histolyticum is the first Food and Drug Administration-approved , nonsurgical treatment option for adult Dupuytren 's contracture patients with a palpable cord that is highly effective and well tolerated . TYPE OF STUDY /LEVEL OF EVIDENCE Therapeutic
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 .