A Phase 3 interventional study of collagenase injection and limited palmar fasciectomy in Dupuytren's Disease, sponsored by McMaster University. Completed at 10 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by McMaster University · Phase 3, Interventional, and Treatment
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.
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.
81 studies on the registry are indexed under Dupuytren Contracture; 17 are open to participants now.
This study's enrollment of 22 is below the median of 72 across 60 interventional studies indexed under Dupuytren Contracture.
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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.
Drug: collagenase injection
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.
Procedure: limited palmar fasciectomy
injection
Also known as: enzyme, collagenase clostridium histolyticum, xiaflex
surgery
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).
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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).
Time frame: 1-4 years
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)
Time frame: 1 year
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)
Time frame: 1 year
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)
Time frame: 1 year
| Milestone | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Started | 8 | 14 |
| Completed | 7 | 9 |
| Not completed | 1 | 5 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Michigan Hand Outcomes Questionnaire (MHQ). Converted to a score rated 0-100 (where higher scores represent better function).
| units on a scale | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) | 78.1 ± 14.9 | 68.3 ± 15.7 |
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.
| units on a scale | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health | 0.8 ± 0.79 | 0.79 ± 0.14 |
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.
| units on a scale | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) | 4.6 ± 9.2 | 5.2 ± 7.6 |
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.
| units on a scale | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) | 6.5 ± 3.2 | 7.2 ± 3.7 |
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.
| quality-adjusted life years | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) | 0.83 ± 1.7 | 0.93 ± 2.8 |
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).
| Participants | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Recurrence Rates | 3 | 1 |
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)
| Degrees | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Loss of Extension MCP | 20 ± 26.9 | 2.56 ± 3.97 |
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)
| Degrees | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Loss of Extension PIP | 23.2 ± 18.17 | 17.2 ± 21.81 |
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)
| Degrees | Collagenase Injection | Limited Palmar Fasciectomy |
|---|---|---|
| Loss of Extension DIP | 8 ± 0 | 10 ± 14.14 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagenase Injection | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Limited Palmar Fasciectomy | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
One participant in the limited palmar fasciectomy (LPF) group dropped out immediately after randomization, before baseline outcomes were measured, thus the size of the LPF group is 13, not 14.
| Age, Continuous(years) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Mean | 65.8 ± 10.2 | 65 ± 9 | 65.3 ± 9.2 |
| Sex: Female, Male(Participants) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 7 | 11 | 18 |
| Race and Ethnicity Not Collected(Participants) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Canada | 8 | 13 | 21 |
| Affected Hand(Participants) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Right | 6 | 9 | 15 |
| Left | 2 | 4 | 6 |
| Affected Digit(Participants) | Collagenase Injection | Limited Palmar Fasciectomy | Total |
|---|---|---|---|
| Little | 2 | 8 | 10 |
| Ring | 1 | 3 | 4 |
| Long | 1 | 0 | 1 |
| Little & Ring | 4 | 0 | 4 |
| Long & Little | 0 | 1 | 1 |
| Little, Ring & Long | 0 | 1 | 1 |
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Studies of the drug tested here: Collagenase