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Completed

NCT Number: NCT02725528

Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collagenase injection

Drug

injection

Other names: enzyme, collagenase clostridium histolyticum, xiaflex

limited palmar fasciectomy

Procedure

surgery

Primary outcomes

  1. 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

  1. HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health

    Time frame: 1 year

    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.

  2. HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM)

    Time frame: 1 year

    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.

  3. HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS)

    Time frame: 1 year

    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.

  4. Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3)

    Time frame: 1 year

    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.

  5. Recurrence Rates

    Time frame: 1-4 years

    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).

  6. Loss of Extension MCP

    Time frame: 1 year

    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)

  7. Loss of Extension PIP

    Time frame: 1 year

    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)

  8. Loss of Extension DIP

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study 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

Acronym: EXTEND

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2016
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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