Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease (NCT03406338) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease
Sweden60 participantsStarted 2018-03-20
Plain-language summary
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
* Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
* Palpable cord in the palm and/or affected finger causing the recurrent contracture.
* No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.
Exclusion Criteria:
* Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
* Signs of nerve or vascular injury in the affected finger.
* Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
* Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
* Previous trauma or other surgery involving the affected finger.
* More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.
* Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
* Patient refusal to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Timeframe: Change from baseline to 3 months
2
Proportion of patients with worsening in total active extension deficit ≥20 degrees