{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Dias J"],"funding":["National Institute for Health Research (NIHR)"],"pagination":["1499-1510"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7616701"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["391(16)"],"pubmed_abstract":["<h4>Background</h4>Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.)."],"journal":["The New England journal of medicine"],"pubmed_title":["Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture."],"pmcid":["PMC7616701"],"funding_grant_id":["15/102/04"],"pubmed_authors":["Arundel C","Torgerson D","Johnson N","Wu Q","Armaou M","Warwick D","Watson M","Knowlson CN","Bainbridge L","Leighton P","Tharmanathan P","Brady S","Hewitt CE","Keding A","James S","Craigen M","Jones J","Flett LG","Welch C","Cooke J","Dias J"],"additional_accession":[]},"is_claimable":false,"name":"Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture.","description":"<h4>Background</h4>Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.).","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Oct","modification":"2025-04-04T23:47:29.562Z","creation":"2025-04-04T23:47:29.562Z"},"accession":"S-EPMC7616701","cross_references":{"pubmed":["39383454"],"doi":["10.1056/NEJMoa2312631"]}}