Surgery with fat grafting for Dupuytren's disease recurrence
Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).
This study is testing whether adding fat grafting to standard surgery for Dupuytren's disease can help prevent the condition from coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 2 sites (Pessac and 1 other locations) |
| Trial ID | NCT05067764 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding autologous adipose tissue grafting to the standard surgical treatment of Dupuytren's disease, known as aponeurectomy. The study aims to compare recurrence rates of Dupuytren's disease in patients who undergo aponeurectomy with and without the fat grafting procedure. The hypothesis is that the adipose tissue may inhibit the recurrence of fibrosis and improve scar quality. The trial will involve a prospective comparative approach with a control group and an experimental group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Tubiana stage II-IV Dupuytren's disease requiring surgical intervention.
Not a fit: Patients who have previously undergone surgery for Dupuytren's disease or those with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rate of Dupuytren's disease after surgery, improving patient outcomes.
How similar studies have performed: This approach is novel, as no other studies have utilized lipofilling as an adjunct to aponeurectomy for Dupuytren's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated * Indication of a surgery by aponeurectomy * Skin pinch of the posterior aspect of the arm of more than 1cm * Affiliation to a social security system * Patient informed of the study and having given informed consent Exclusion Criteria: * Previous surgery of any kind for Dupuytren's disease * Involvement on the thumb only * Need for a total skin graft or a pedicle flap on all the rays to be treated * Active autoimmune disease * Previous treatment with collagenase * Pregnant and breastfeeding women * Patient under legal protection * Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers)
Where this trial is running
Pessac and 1 other locations
- Institut Aquitain de la Main — Pessac, France (Recruiting)
- Santé Atlantique ELSAN — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: Elias SAWAYA, MD — Institut Aquitain de la Main
- Study coordinator: Elias SAWAYA, MD
- Email: esawaya.md@gmail.com
- Phone: (0)663420278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.