Prospective Randomized Controlled Trial Comparing 1 Day Versus 7 Day Manipulation Following Collagenase Injection for the Treatment of Dupuytren's Contracture

Purpose:

The use of Collagenase clostridium histolyticum (CCH) injection followed by manipulation at 1 day has become a common treatment option for Dupuytren’s contracture. We hypothesize that manual manipulation at 7 days following injection has similar efficacy, tolerance and safety.

Methods:

Eligible patients were randomized to manipulation at 1 day versus 7 day following CCH injection. Pre-injection, pre-manipulation, post-manipulation, and 30 day follow-up metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joint contractures were measured. Injection, pre-manipulation, and manipulation pain scores were recorded. Skin tears and tendon ruptures were noted. Data was stratified per cohort based on primary joint treated (MCP versus PIP). Means were compared using paired and unpaired t-tests.

Results:

Forty-three patients with 46 digits were eligible for randomization and treatment. There were 22 digits randomized to 1 day manipulation and 24 digits randomized to 7 day manipulation. Subjects included 35 males and 8 females with mean age 63. There were no significant differences between cohorts for primary MCP or PIP treated in initial, post-manipulation, or 30 day follow-up contractures. Mean MCP joint contracture reduction at 30 days was 46° in the 1 day group and 44° in the 7 day group. Mean PIP joint contracture reduction at 30 days was 50° in the 1 day group and 45° in the 7 day group. There was no difference in manipulation pain. The incidence of skin tears was 6 for the 1 day cohort and 9 for the 7 day cohort. No flexor tendon ruptures were experienced.

Discussion:

The effectiveness of CCH in achieving correction of Dupuytren’s contractures is preserved when manipulation is performed at 7 days. There is no difference in pain or skin tears. This data suggests that manipulation can be scheduled at the convenience of the patient and surgeon between the 1 day and 7 days after injection.

 

Level of Evidence = 1 (Prospective Open Label Randomized Controlled Trial)

Keywords = Collagenase clostridium histolyticum, Dupuytren’s contracture, Follow-up, Injection, Timing