Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

NCT ID: NCT03406338

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2027-09-30

Brief Summary

This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.

Detailed Description

No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.

Conditions

Dupuytren Disease of Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgical fasciectomy

Fasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures

Group Type: ACTIVE_COMPARATOR

Fasciectomy

Intervention Type: PROCEDURE

Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.

Collagenase Clostridium Histolyticum

Injection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures

Group Type: EXPERIMENTAL

Collagenase Clostridium Histolyticum

Intervention Type: DRUG

Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia

Interventions

Fasciectomy

Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.

Intervention Type: PROCEDURE

Collagenase Clostridium Histolyticum

Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia

Intervention Type: DRUG

Other Intervention Names

Surgery; Non-surgical treatment

Eligibility Criteria

Inclusion Criteria

• Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
• Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
• Palpable cord in the palm and/or affected finger causing the recurrent contracture.
• No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.

Exclusion Criteria

• Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
• Signs of nerve or vascular injury in the affected finger.
• Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
• Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
• Previous trauma or other surgery involving the affected finger.
• More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.
• Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
• Patient refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Isam Atroshi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isam Atroshi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Department of Orthopedics Hässleholm-Kristianstad

Hässleholm, , Sweden

Countries

Sweden

References

Nordenskjold J, Lauritzson A, Walden M, Kopylov P, Atroshi I. Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e024424. doi: 10.1136/bmjopen-2018-024424.

Reference Type: DERIVED

PMID: 30808670 (View on PubMed)

Other Identifiers

Hlm_DC

Identifier Type: -

Identifier Source: org_study_id