CompletedPhase 3

Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

Canada22 participantsStarted 2017-07-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ)

Timeframe: 1 year

Trial details

NCT IDNCT02725528

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-17

Results submitted2023-04-25

View on ClinicalTrials.gov More Dupuytren's Disease trials