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Short-term efficacy and safety of collagenase injection for Dupuytren's contracture: Therapy protocol for successful outcomes in a clinical setting.

PURPOSE: To assess the short-term efficacy and safety of collagenase injection for Dupuytren's contracture and of our post-injection therapy protocol alternative the instruction of phase III studies at clinical setting.

METHODS: The retrospective study included 23 fingers of 21 hands of 18 patients for primary metacarpophalangeal (MP) joints and 11 fingers of 10 hands of 10 patients for primary proximal interphalangeal (PIP) joints with Dupuytren's contracture who were treated with 0.58 mg collagenase Clostridium histolyticum (CCH) injections at our hospital consecutively from September 2015 to October 2017. The mean age of the patients was 73.0 years (range, 57-88) for primary MP joints and 70.7 years (61-81) for primary PIP joints. Following standard CCH injection and manipulation on the next day, certified hand surgeons evaluated and treated each patient based on a defined 4-week therapy protocol that consisted of performing finger exercises during the day and wearing static extension splint at night for all cases, and of wearing Capener dynamic splint intervention to address severely contracted PIP joints. We measured the degree of contracture at baseline, immediately, 4 weeks, and 12 weeks after the last manipulation.

RESULTS: More improvement of contracture was seen in the MP joints than in the PIP joints. For the five fingers severely contracted and treated with Capener splint intervention, the mean passive PIP joint contracture was 62.0° at baseline, 21.0° immediately, further improved to 6.0° by 4 weeks, and maintained 8.0° by 12 weeks after the last manipulation. The adverse events were mild-to-moderate local reactions in the injected hand.

CONCLUSIONS: The clinical efficacy and safety of CCH were confirmed in a clinical setting similar to phase III studies. The improvement of 4-week-intervention was maintained at 12 weeks after the last manipulation. Severely contracted PIP joints could benefit from Capener splint intervention.

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