Clinical trial NCT02725528: Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2016-04-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: 1 year
Secondary outcomes:
measure: HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health
timeFrame: 1 year
measure: HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM)
timeFrame: 1 year
measure: HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS)
timeFrame: 1 year
measure: Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3)
timeFrame: 1 year
measure: Recurrence Rates
timeFrame: 1-4 years
measure: Loss of Extension MCP
timeFrame: 1 year
measure: Loss of Extension PIP
timeFrame: 1 year
measure: Loss of Extension DIP
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare / McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
city: Newmarket
country: Canada
facility: 679 Davis St. Suite 209
state: Ontario
city: Oakville
country: Canada
facility: Halton Healthcare Services
state: Ontario
city: Oakville
country: Canada
facility: Oakville Trafalgar Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Achilleas Thoma, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: