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 .
The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study.
PURPOSE To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum ( CCH ) injections to treat 2 joints in the same h and with Dupuytren fixed flexion contractures ( FFCs ) . METHODS Patients with 2 or more contractures in the same h and caused by palpable cords participated in a 60-day , multicenter , open-label , phase 3b study . Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same h and ( 1 injection per affected joint ) during the same visit . Finger extension was performed approximately 24 , 48 , or 72 or more hours later . Changes in FFC and range of motion , incidence of clinical success ( FFC ≤ 5 ° ) , and adverse events ( AEs ) were summarized . RESULTS The study enrolled 715 patients ( 725 treated joint pairs ) , and 714 patients ( 724 joint pairs ) were analyzed for efficacy . At day 31 , mean total FFC ( sum of 2 treated joints ) decreased 74 % , from 98 ° to 27 ° . Mean total range of motion increased from 90 ° to 156 ° . The incidence of clinical success was 65 % in metacarpophalangeal joints and 29 % in proximal interphalangeal joints . Most treatment-related AEs were mild to moderate , resolving without intervention ; the most common were swelling of treated extremity , contusion , and pain in extremity . The incidence of skin lacerations was 22 % ( 160 of 715 ) . Efficacy and safety were similar regardless of time to finger extension . CONCLUSIONS Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint , with the exception of skin laceration . The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint . Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints , and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment
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 .