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Trial question
Is collagenase injection noninferior to limited fasciectomy in patients with Dupuytren's contracture?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 672
672 patients (139 female, 533 male).
Inclusion criteria: patients with moderate Dupuytren's contracture.
Key exclusion criteria: severe contracture; previous treatment of the digit being studied in the trial; preexisting disorder affecting hand function or increasing the risk of adverse effects during trial participation; coagulation disorder; pregnancy or lactation.
Interventions
N=336 collagenase injection (injection of collagenase in 3 aliquots at set points with rupture of cord by manipulation).
N=336 limited fasciectomy (outpatient surgery to remove diseased cords).
Primary outcome
Mean Patient Evaluation Measure-Hand Health Profile score at 1 year
17.8 points
11.9 points
17.8 points
13.4 points
8.9 points
4.5 points
0.0 points
Collagenase injection
Limited fasciectomy
Difference exceeding non-inferiority margin ✗
Difference exceeding non-inferiority margin in mean Patient Evaluation Measure-Hand Health Profile score at 1 year (17.8 points vs. 11.9 points; MD 5.9, 95% CI 3.1 to 8.8).
Secondary outcomes
Significant increase in mean Patient Evaluation Measure-Hand Health Profile score at 2 years (19.2 points vs. 12.2 points; MD 7.2, 95% CI 4.2 to 10.9).
No significant difference in recurrence of Dupuytren's contracture (17.2% vs. 13.8%; AD 4%, 95% CI -3.7 to 11.7).
Significant increase in mean passive extension deficit of reference joint at 1 year (13 degrees vs. 4 degrees; MD 10.1, 95% CI 6.7 to 13.7).
Safety outcomes
No significant difference in overall complications.
Significant difference in moderate or severe complications (1.8% vs. 5.1%).
Conclusion
In patients with moderate Dupuytren's contracture, collagenase injection was not noninferior to limited fasciectomy with respect to mean Patient Evaluation Measure-Hand Health Profile score at 1 year.
Reference
Joseph Dias, Puvanendran Tharmanathan, Catherine Arundel et al. Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture. N Engl J Med. 2024 Oct 24;391(16):1499-1510.
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