Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

NCT03406338 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Hlm_DC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren Disease of Finger

Outcome Measures

Primary Outcomes (2)

• Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)

  Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)

  Change from baseline to 3 months

• Proportion of patients with worsening in total active extension deficit ≥20 degrees

  Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)

  24 months compared to 3 months

Secondary Outcomes (12)

• 11-item disabilities of the arm, shoulder and hand (QuickDASH) score

  Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months

• EuroQoL 5-dimensions (EQ-5D) Index

  Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months

• Pain score

  Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months

• Satisfaction score

  3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months

• Adverse events

  Anytime during 24 months after treatment

Study Arms (2)

Surgical fasciectomy

ACTIVE COMPARATOR

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

Procedure: Fasciectomy

Collagenase Clostridium Histolyticum

EXPERIMENTAL

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

Drug: Collagenase Clostridium Histolyticum

Interventions

Fasciectomy 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.

Also known as: Surgery

Surgical fasciectomy

Collagenase Clostridium Histolyticum DRUG

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

Also known as: Non-surgical treatment

Collagenase Clostridium Histolyticum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Orthopedics Hässleholm-Kristianstad

Hässleholm, SE 28125, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30808670 DERIVED

MeSH Terms

Interventions

Fasciotomy; Surgical Procedures, Operative; Microbial Collagenase

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Isam Atroshi, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Before examination the patients will wear thin gloves in the treated hands to conceal possible surgical scars so the examiner will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized parallel Group, ratio 1:1.

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 23, 2018
• Study Start: March 20, 2018
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)