Phase 3
N=22
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
Dupuytren's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02725528 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) — 78.1; 68.3 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- collagenase injection (Drug); limited palmar fasciectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) |
78.1; 68.3 | 0.05 |
| SECONDARY HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health |
0.8; 0.79 | 0.05 |
| SECONDARY HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) |
4.6; 5.2 | 0.05 |
| SECONDARY HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) |
6.5; 7.2 | 0.05 |
| SECONDARY Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) |
0.83; 0.93 | 0.05 |
| SECONDARY Recurrence Rates |
3; 1 | 0.05 |
| SECONDARY Loss of Extension MCP |
20; 2.56 | 0.05 |
| SECONDARY Loss of Extension PIP |
23.2; 17.2 | 0.05 |
| SECONDARY Loss of Extension DIP |
8; 10 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Canadian Citizen
- 18 years of age or older
- 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)
- Demonstrated inability to simultaneously place the affected finger and palm flat on a table
- Able to understand and communicate in English
Exclusion Criteria
- Previous treatment of the primary joint within 90 days of study inclusion
- Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release)
- Persistent extension deficit from a previous surgery of the same digit
- Any chronic muscular or neuromuscular disorder affecting wrist or hand
- Patient generally unfit for surgery
- Patient with specific treatment preference
- Bleeding disorder or recent stroke
- Allergy to collagenase
- Collagenase treatment or treatment with any investigational drug within 30 days of study inclusion
- 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])
- Pregnant or breast feeding patients
- Patients who do not have insurance coverage for collagenase injections
- 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.
Data sourced from ClinicalTrials.gov (NCT02725528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.