N Engl J Med
Study compares Dupuytren’s contracture treatments
October 16, 2024
With respect to the score on the Patient Measure-Hand Health Profile (PEM) at 1 year, collagenase injection wasn’t noninferior to limited fasciectomy.
This unblinded, pragmatic, randomized, controlled noninferiority trial compared collagenase injection with limited fasciectomy in patients with moderate Dupuytren’s contracture. Primary outcome was the score on the PEM at 1 year after treatment. PEM scores range from 0 to 100, with higher scores indicating worse outcomes. Prespecified noninferiority margin was 6 points.
The trial enrolled 672 participants who were assigned (1:1) to receive collagenase injection or to undergo limited fasciectomy. Primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. Among participants with available data, mean PEM score at 1 year was 17.8 in the collagenase group and 11.9 in the limited-fasciectomy group (estimated difference, 5.9 points; 95% CI, 3.1-8.8; one-sided P = 0.49 for noninferiority). The estimated difference in mean PEM score at 2 years was 7.2 points (95% CI, 4.2-10.9). The rate of moderate or severe treatment complications was 1.8% in the collagenase group vs. 5.1% in the limited-fasciectomy group. Rates of recurrent contracture resulting in reintervention were 14.6% and 3.4% in the collagenase and limited fasciotomy groups, respectively.
Source:
Dias J, et al. (2024, October 9). N Engl J Med. Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture. https://pubmed.ncbi.nlm.nih.gov/39383454/
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