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Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial.
J Hand Surg Am. 2017 May; 42(5):321-328.e3.JH

Abstract

PURPOSE

Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use.

METHOD

In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score.

RESULTS

Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed.

CONCLUSIONS

This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF.

TYPE OF STUDY/LEVEL OF EVIDENCE

Therapeutic I.

Authors+Show Affiliations

Interdisciplinary Research Unit, Center for Planned Surgery, Silkeborg, Denmark; Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark. Electronic address: simon.skov@clin.au.dk.Center for Planned Surgery, Regional Hospital Silkeborg, Silkeborg, Denmark.Center for Planned Surgery, Regional Hospital Silkeborg, Silkeborg, Denmark.Interdisciplinary Research Unit, Center for Planned Surgery, Silkeborg, Denmark; Orthopaedic Research Unit, Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28473158

Citation

Skov, Simon Toftgaard, et al. "Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: a Randomized Controlled Trial." The Journal of Hand Surgery, vol. 42, no. 5, 2017, pp. 321-328.e3.
Skov ST, Bisgaard T, Søndergaard P, et al. Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial. J Hand Surg Am. 2017;42(5):321-328.e3.
Skov, S. T., Bisgaard, T., Søndergaard, P., & Lange, J. (2017). Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial. The Journal of Hand Surgery, 42(5), 321-e3. https://doi.org/10.1016/j.jhsa.2017.03.003
Skov ST, et al. Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: a Randomized Controlled Trial. J Hand Surg Am. 2017;42(5):321-328.e3. PubMed PMID: 28473158.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Injectable Collagenase Versus Percutaneous Needle Fasciotomy for Dupuytren Contracture in Proximal Interphalangeal Joints: A Randomized Controlled Trial. AU - Skov,Simon Toftgaard, AU - Bisgaard,Therkel, AU - Søndergaard,Per, AU - Lange,Jeppe, PY - 2016/10/19/received PY - 2017/03/01/accepted PY - 2017/5/6/entrez PY - 2017/5/6/pubmed PY - 2018/3/17/medline KW - Dupuytren contracture KW - collagenase Clostridium histolyticum KW - outcome KW - percutaneous needle fasciotomy KW - randomized controlled trial SP - 321 EP - 328.e3 JF - The Journal of hand surgery JO - J Hand Surg Am VL - 42 IS - 5 N2 - PURPOSE: Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use. METHOD: In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. RESULTS: Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. CONCLUSIONS: This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I. SN - 1531-6564 UR - https://www.unboundmedicine.com/medline/citation/28473158/Injectable_Collagenase_Versus_Percutaneous_Needle_Fasciotomy_for_Dupuytren_Contracture_in_Proximal_Interphalangeal_Joints:_A_Randomized_Controlled_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0363-5023(16)30817-6 DB - PRIME DP - Unbound Medicine ER -