Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture

Joseph Dias; Puvanendran Tharmanathan; Catherine Ellen Arundel; Charlie Welch; Qi Wu; Paul Leighton; Maria Armaou; Nick Johnson; Sophie Jane James; John Cooke; Lionel Bainbridge; Michael Craigen; David  Warwick; Samantha Brady; Lydia Georgina Flett; Judy Jones; Catherine N Knowlson; Michelle Storm Watson; Ada Keding; Catherine Elizabeth Hewitt; David John Torgerson

doi:10.1056/NEJMoa2312631

Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture

Joseph Dias, Puvanendran Tharmanathan, Catherine Ellen Arundel, Charlie Welch, Qi Wu, Paul Leighton, Maria Armaou, Nick Johnson, Sophie Jane James, John Cooke, Lionel Bainbridge, Michael Craigen, David Warwick, Samantha Brady, Lydia Georgina Flett, Judy Jones, Catherine N Knowlson, Michelle Storm Watson, Ada Keding, Catherine Elizabeth HewittDavid John Torgerson

Health Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

Background
Treatments for Dupuytren’s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited.

Methods
We performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupuytren’s contracture. The primary outcome was the score on the Patient Evaluation Measure Hand Health Questionnaire (range 0 to 100, higher scores indicating worse outcome) 1-year post-treatment. The pre-specified non-inferiority margin was 6 points.

Results
672 participants were randomized (n=336 per group). Primary analysis included 599 (314 collagenase; 285 limited fasciectomy).
At 1-year, the mean score on the Hand Health questionnaire was 17.8 in the collagenase group (n = 284) and 11.9 in the limited fasciectomy group (n = 250); between group difference = 5.9 (95%CI: 3.1 to 8.8, one sided p value for non-inferiority 0.49). At 2 years (n = 229 and n = 197 in collagenase and limited fasciectomy groups, respectively), the between group difference was 7.2 (95%CI: 4.2 to 10.9). The percentage of persons with moderate to severe complications was 2% in the collagenase group and 5% in the limited fasciectomy group. Recurrent contracture requiring re-intervention occurred in 8% after collagenase versus 1.7% after limited fasciectomy.

Conclusions
Collagenase was not non-inferior to limited fasciectomy with respect to the Patient Evaluation Measure hand health questionnaire score at 1-year post-treatment.

(Supported by NIHR Health Technology Assessment programme; Trial registration: ISRCTN18254597)

Original language	English
Journal	New England Journal of Medicine
DOIs	https://doi.org/10.1056/NEJMoa2312631
Publication status	Published - 9 Oct 2024

Bibliographical note

This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.

Access to Document

10.1056/NEJMoa2312631

DISC Final Accepted version pre proof
This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.
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Cite this

Dias, J., Tharmanathan, P., Arundel, C. E., Welch, C., Wu, Q., Leighton, P., Armaou, M., Johnson, N., James, S. J., Cooke, J., Bainbridge, L., Craigen, M., Warwick, D., Brady, S., Flett, L. G., Jones, J., Knowlson, C. N., Watson, M. S., Keding, A., ... Torgerson, D. J. (2024). Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture. New England Journal of Medicine . https://doi.org/10.1056/NEJMoa2312631

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title = "Collagenase Injection versus Limited Fasciectomy for Dupuytren{\textquoteright}s Contracture",

abstract = "BackgroundTreatments for Dupuytren{\textquoteright}s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited.MethodsWe performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupuytren{\textquoteright}s contracture. The primary outcome was the score on the Patient Evaluation Measure Hand Health Questionnaire (range 0 to 100, higher scores indicating worse outcome) 1-year post-treatment. The pre-specified non-inferiority margin was 6 points. Results672 participants were randomized (n=336 per group). Primary analysis included 599 (314 collagenase; 285 limited fasciectomy). At 1-year, the mean score on the Hand Health questionnaire was 17.8 in the collagenase group (n = 284) and 11.9 in the limited fasciectomy group (n = 250); between group difference = 5.9 (95%CI: 3.1 to 8.8, one sided p value for non-inferiority 0.49). At 2 years (n = 229 and n = 197 in collagenase and limited fasciectomy groups, respectively), the between group difference was 7.2 (95%CI: 4.2 to 10.9). The percentage of persons with moderate to severe complications was 2% in the collagenase group and 5% in the limited fasciectomy group. Recurrent contracture requiring re-intervention occurred in 8% after collagenase versus 1.7% after limited fasciectomy. ConclusionsCollagenase was not non-inferior to limited fasciectomy with respect to the Patient Evaluation Measure hand health questionnaire score at 1-year post-treatment. (Supported by NIHR Health Technology Assessment programme; Trial registration: ISRCTN18254597)",

author = "Joseph Dias and Puvanendran Tharmanathan and Arundel, {Catherine Ellen} and Charlie Welch and Qi Wu and Paul Leighton and Maria Armaou and Nick Johnson and James, {Sophie Jane} and John Cooke and Lionel Bainbridge and Michael Craigen and David Warwick and Samantha Brady and Flett, {Lydia Georgina} and Judy Jones and Knowlson, {Catherine N} and Watson, {Michelle Storm} and Ada Keding and Hewitt, {Catherine Elizabeth} and Torgerson, {David John}",

note = "This is an author-produced version of the published paper. Uploaded in accordance with the University{\textquoteright}s Research Publications and Open Access policy. ",

year = "2024",

month = oct,

day = "9",

doi = "10.1056/NEJMoa2312631",

language = "English",

journal = "New England Journal of Medicine ",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

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Dias, J, Tharmanathan, P , Arundel, CE , Welch, C , Wu, Q, Leighton, P, Armaou, M, Johnson, N, James, SJ, Cooke, J, Bainbridge, L, Craigen, M, Warwick, D, Brady, S , Flett, LG, Jones, J, Knowlson, CN, Watson, MS , Keding, A , Hewitt, CE & Torgerson, DJ 2024, 'Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture', New England Journal of Medicine . https://doi.org/10.1056/NEJMoa2312631

TY - JOUR

T1 - Collagenase Injection versus Limited Fasciectomy for Dupuytren’s Contracture

AU - Dias, Joseph

AU - Tharmanathan, Puvanendran

AU - Arundel, Catherine Ellen

AU - Welch, Charlie

AU - Wu, Qi

AU - Leighton, Paul

AU - Armaou, Maria

AU - Johnson, Nick

AU - James, Sophie Jane

AU - Cooke, John

AU - Bainbridge, Lionel

AU - Craigen, Michael

AU - Warwick, David

AU - Brady, Samantha

AU - Flett, Lydia Georgina

AU - Jones, Judy

AU - Knowlson, Catherine N

AU - Watson, Michelle Storm

AU - Keding, Ada

AU - Hewitt, Catherine Elizabeth

AU - Torgerson, David John

N1 - This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.

PY - 2024/10/9

Y1 - 2024/10/9

N2 - BackgroundTreatments for Dupuytren’s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited.MethodsWe performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupuytren’s contracture. The primary outcome was the score on the Patient Evaluation Measure Hand Health Questionnaire (range 0 to 100, higher scores indicating worse outcome) 1-year post-treatment. The pre-specified non-inferiority margin was 6 points. Results672 participants were randomized (n=336 per group). Primary analysis included 599 (314 collagenase; 285 limited fasciectomy). At 1-year, the mean score on the Hand Health questionnaire was 17.8 in the collagenase group (n = 284) and 11.9 in the limited fasciectomy group (n = 250); between group difference = 5.9 (95%CI: 3.1 to 8.8, one sided p value for non-inferiority 0.49). At 2 years (n = 229 and n = 197 in collagenase and limited fasciectomy groups, respectively), the between group difference was 7.2 (95%CI: 4.2 to 10.9). The percentage of persons with moderate to severe complications was 2% in the collagenase group and 5% in the limited fasciectomy group. Recurrent contracture requiring re-intervention occurred in 8% after collagenase versus 1.7% after limited fasciectomy. ConclusionsCollagenase was not non-inferior to limited fasciectomy with respect to the Patient Evaluation Measure hand health questionnaire score at 1-year post-treatment. (Supported by NIHR Health Technology Assessment programme; Trial registration: ISRCTN18254597)

AB - BackgroundTreatments for Dupuytren’s contracture include limited fasciectomy and collagenase injection. Evidence comparing these treatments is limited.MethodsWe performed an unblinded, multicenter, pragmatic, two-arm, randomized controlled non-inferiority trial comparing collagenase injection to limited fasciectomy in persons with moderate Dupuytren’s contracture. The primary outcome was the score on the Patient Evaluation Measure Hand Health Questionnaire (range 0 to 100, higher scores indicating worse outcome) 1-year post-treatment. The pre-specified non-inferiority margin was 6 points. Results672 participants were randomized (n=336 per group). Primary analysis included 599 (314 collagenase; 285 limited fasciectomy). At 1-year, the mean score on the Hand Health questionnaire was 17.8 in the collagenase group (n = 284) and 11.9 in the limited fasciectomy group (n = 250); between group difference = 5.9 (95%CI: 3.1 to 8.8, one sided p value for non-inferiority 0.49). At 2 years (n = 229 and n = 197 in collagenase and limited fasciectomy groups, respectively), the between group difference was 7.2 (95%CI: 4.2 to 10.9). The percentage of persons with moderate to severe complications was 2% in the collagenase group and 5% in the limited fasciectomy group. Recurrent contracture requiring re-intervention occurred in 8% after collagenase versus 1.7% after limited fasciectomy. ConclusionsCollagenase was not non-inferior to limited fasciectomy with respect to the Patient Evaluation Measure hand health questionnaire score at 1-year post-treatment. (Supported by NIHR Health Technology Assessment programme; Trial registration: ISRCTN18254597)

U2 - 10.1056/NEJMoa2312631

DO - 10.1056/NEJMoa2312631

M3 - Article

SN - 0028-4793

JO - New England Journal of Medicine

JF - New England Journal of Medicine

ER -