Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McMaster University
• Collaborator: The Physicians' Services Incorporated Foundation

Criteria

Inclusion Criteria:

1. Canadian Citizen

2. 18 years of age or older

3. Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at least 1 finger (not the thumb)

4. Demonstrated inability to simultaneously place the affected finger and palm flat on a table

5. Able to understand and communicate in English

Exclusion Criteria:

1. Previous treatment of the primary joint within 90 days of study inclusion

2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release)

3. Persistent extension deficit from a previous surgery of the same digit

4. Any chronic muscular or neuromuscular disorder affecting wrist or hand

5. Patient generally unfit for surgery

6. Patient with specific treatment preference

7. Bleeding disorder or recent stroke

8. Allergy to collagenase

9. Collagenase treatment or treatment with any investigational drug within 30 days of study inclusion

10. Use of a tetracycline derivative within 14 days of first dose of study drug (because tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs [i.e., matrix metalloproteinases])

11. Pregnant or breast feeding patients

12. Patients who do not have insurance coverage for collagenase injections

13. Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or neuro-psychological problems.