Actively Recruiting
Effectiveness of Percutaneous Needle Aponeurotomy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02
120
Participants Needed
4
Research Sites
432 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease. Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
CONDITIONS
Official Title
Effectiveness of Percutaneous Needle Aponeurotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed Dupuytren's disease with a palpable fibrotic nodule or cord from the palmar aponeurosis
- At least one flexion contracture of a metacarpophalangeal joint of 20 degrees or more due to Dupuytren's disease
- Signed written informed consent
- Affiliated with social security
You will not qualify if you...
- Other musculoskeletal disorders of the hand besides Dupuytren's disease, including inflammatory rheumatic disease or joint pain at the time of inclusion
- Prior surgery on the hand to be treated causing functional or mobility limitations
- Any other pathological condition or limited finger motion in the hand to be treated
- Psychiatric conditions preventing evaluation, vulnerability, legal protection status, or incapacity to give consent
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centre d'Imagerie Médicale Bachaumont Paris Centre
Paris, France, 75002
Active, Not Recruiting
2
Hopital LARIBOISIERE - Radiologie
Paris, France, 75010
Active, Not Recruiting
3
Hopital LARIBOISIERE - Rhumatologie
Paris, France, 75010
Actively Recruiting
4
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Paris, France, 75016
Actively Recruiting
Research Team
J
Johann BEAUDREUIL, PUPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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