A Multi-Center, Randomized Controlled Trial Comparing The Clinical Effectiveness and Cost-Effectiveness of Collagenase Injection (Xiaflex) and Palmar Fasciectomy in the Management of Dupuytren's Disease
Overview
- Phase
- Phase 3
- Intervention
- collagenase injection
- Conditions
- Dupuytren's Disease
- Sponsor
- McMaster University
- Enrollment
- 22
- Locations
- 10
- Primary Endpoint
- Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
Limited palmar fasciectomy (LPF) and collagenase injection (CI) are the most common procedures to manage symptoms of Dupuytren's Disease. This randomized controlled trial (RCT) aimed to directly compare patient outcomes 12 months following CI and LPF. Twenty-two patients with Dupuytren's Disease were randomized to either LPF or CI. The primary outcome was health state measured by the Michigan Hand Questionnaire. Secondary outcomes were health status (The Health Utility Index-3), function (The Unité Rhumatologique des Affections de la Main and The Southampton Dupuytren's Scoring Scheme), and range of motion (ROM) of treated digits. Measurements were collected at baseline and 1-, 3-, 6-, and 12-months post-procedure.
Investigators
Achilleas Thoma
Dr. Achllieas Thoma
McMaster University
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 \[i.e., matrix metalloproteinases\])
Arms & Interventions
collagenase injection
This procedure will be performed either in a minor procedure room or the hand clinic as per surgeon's routine practice. Collagenase will be administered with or without local anesthesia. As this is a pragmatic study there may be more than one digit injected at a time just as surgery occurs on more than one digit at a time. A recently published study by Gaston et al confirmed that two concurrent injections of collagenase to 2 affected joints in the same hand are generally well tolerated and the frequency of most adverse events (AEs) is similar to those reported in studies that use single sequential injections.
Intervention: collagenase injection
limited palmar fasciectomy
The Dupuytren's cord will be excised under local anesthesia in a minor procedure room setting or main operating room under local or general anesthetic depending on the complexity of the disease and the surgeon's routine. As this is a pragmatic study comparison of collagenase injections (novel intervention) to limited palmar fasciectomy as it is actually presently performed in all settings academic or community (local in minor room or general/local anesthetic in the main operating room) will be examined. Surgery will be performed according to the operating surgeon's preferred technique i.e. zig-zag Brunner incision or straight incision with z-plasty closure of the skin.
Intervention: limited palmar fasciectomy
Outcomes
Primary Outcomes
Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: 1 year
Michigan Hand Outcomes Questionnaire (MHQ). Converted to a score rated 0-100 (where higher scores represent better function).
Secondary Outcomes
- Loss of Extension DIP(1 year)
- HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health(1 year)
- Recurrence Rates(1-4 years)
- Loss of Extension MCP(1 year)
- Loss of Extension PIP(1 year)
- HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM)(1 year)
- HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS)(1 year)
- Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3)(1 year)