Collagenase not noninferior for Dupuytren contracture

For patients with moderate Dupuytren contracture, collagenase injection is not noninferior to limited fasciectomy, according to a study published online Oct. 9 in the New England Journal of Medicine.

Joseph Dias, M.D., from Leicester General Hospital in the United Kingdom, and colleagues conducted a pragmatic, randomized, controlled, noninferiority trial comparing collagenase injection to limited fasciectomy among individuals with moderate Dupuytren contracture. The score on the Patient Evaluation Measure-Hand Health Profile (PEM), as reported by the patient at one year after treatment, was the primary outcome.

Overall, 336 patients were assigned to receive collagenase injection and 336 were assigned to undergo limited fasciectomy; the primary analysis included 314 and 285 individuals, respectively. The researchers found that the mean score on the PEM at one year was 17.8 and 11.9 among patients with available data in the collagenase injection and limited fasciectomy groups, respectively (estimated difference, 5.9 points; one-sided P = 0.49 for noninferiority). At two years, the estimated difference in the mean score on the PEM was 7.2. Moderate or severe complications from treatment occurred in 1.8 and 5.1 percent of patients in the collagenase and limited-fasciectomy groups, respectively; reintervention due to recurrent contracture occurred in 14.6 and 3.4 percent, respectively.

“Collagenase was not noninferior to limited fasciectomy with respect to the score on the PEM at one year after treatment,” the authors write.

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