Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

Dupuytren's Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725528
• Other study ID #: PSI 2016-03
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2017
• Est. completion date: December 17, 2021

Study information

• Verified date: June 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Drug:
• collagenase injection
injection

Procedure:
• limited palmar fasciectomy
surgery

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare / McMaster University	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	679 Davis St. Suite 209	Newmarket	Ontario
Canada	Halton Healthcare Services	Oakville	Ontario
Canada	Oakville Trafalgar Hospital	Oakville	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	North York General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ)	Michigan Hand Outcomes Questionnaire (MHQ). Converted to a score rated 0-100 (where higher scores represent better function).	1 year
Secondary	HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health	Health Utility Index Mark 3 (HUI3) of Health. The HUI3 is a generic multi-attribute health-status classification instrument composed of eight attributes or dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain with five or six levels per attribute. Dimensions are combined to produce one health utility score. The HUI3 produces health utilities anchored at 0 (minimum) for equal to being dead and 1 (maximum) for perfect health.	1 year
Secondary	HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM)	Unité Rhumatologique des Affections de la Main (URAM). The URAM is a disease-specific HRQL measure developed for Dupuytren's Disease (DD) and is composed of a 9-item patient-reported questionnaire. Each item is scored between 0 and 5 depending on the difficulty in performing that particular function with total scores for DD-associated disability ranging from 0 (best) to 45 (worst). High scores suggest high levels of disability and disturbance. The URAM scale is a 1-domain outcome measure postulated to be related to disability associated with DD.	1 year
Secondary	HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS)	The SDSS is disease-specific scoring system developed for Dupuytren's Disease (DD) with 5 domains, each relevant to DD and scored on a five-point scale (no problem, mild inconvenience, modest inconvenience, definitely troublesome, severe problem). The minimum score is 0 and maximum score is 20 with higher scores suggesting higher levels of disability.	1 year
Secondary	Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3)	QALY was calculated by multiplying the difference between quality of life, as measured by the HUI-3 score before and after the intervention by the remaining years of life of the average patient (i.e., life expectancy - patient's age). Life expectancy was set at 79 years for males, and 84 years for females. Higher QALYs represent improved (better) patient outcomes.	1 year
Secondary	Recurrence Rates	Reccurence was measured as whether or not participants received a repeat diagnosis of Dupuytren's disease with loss of finger extension at the site of prior intervention and underwent palmar fasciectomy (following the collagenase injection or as a revision operation) after initial study treatment. The time horizon for recurrence was between 1-4 years post initial study treatment. Outcome was dichotomous (i.e., recurrence; yes or no).	1-4 years
Secondary	Loss of Extension MCP	Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the metacarpal-phalangeal joint, relative to a metacarpal-phalangeal joint at full extension (i.e., 0 degrees)	1 year
Secondary	Loss of Extension PIP	Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the proximal inter-phalangeal joint, relative to a proximal inter-phalangeal joint at full extension (i.e., 0 degrees)	1 year
Secondary	Loss of Extension DIP	Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the distal inter-phalangeal joint, relative to a distal inter-phalangeal joint at full extension (i.e., 0 degrees)	1 year