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Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture
Joseph Dias1, Puvanendran Tharmanathan1, Catherine Arundel1
1From the Academic Team of Musculoskeletal Surgery, Undercroft, Leicester General Hospital, University Hospitals of Leicester NHS Trust (J.D., M.A., J.J.), Leicester (J.C.), the York Trials Unit (P.T., C.A., C.W., S.J., S.B., L.G.F., C.N.K., M.W., A.K., C.E.H., D.T.) and the Department of Health Sciences (Q.W.), University of York, York, the University of Nottingham, Nottingham (P.L.), University Hospitals of Derby and the Burton NHS Trust, Derby (N.J., L.B.), the Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham (M.C.), and the University Hospital Southampton NHS Foundation Trust, Southampton (D.W.) - all in the United Kingdom.
Background:
Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited.
Methods:
We performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), a questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEM range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points.
Results:
A total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at 1 year was 17.8 among the 284 patients with available data in the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95% confidence interval [CI], 3.1 to 8.8; one-sided P = 0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7.2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1% of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively.
Conclusions:
Collagenase injection was not noninferior to limited fasciectomy with respect to the score on the PEM at 1 year after treatment. (Funded by the National Institute for Health and Care Research Health Technology Assessment Programme; DISC ISRCTN Registry number ISRCTN18254597.).
