Status:
RECRUITING
Effectiveness of Percutaneous Needle Aponeurotomy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Dupuytren Disease of Finger
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 hypoth...
Detailed Description
Scientific justification: Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarp...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
- Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and \> or = 20°
- Written informed consent signed by the patient
- Patient affiliated to the social security
Exclusion
- Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit.
- Previous surgery of the hand to be treated resulting in functional limitation or limitation of finger mobility
- Any other pathological condition or limited range of motion in the finger to be treated
- Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.
- Pregnant or beastfeeding women
- Participation in another interventional trial
Key Trial Info
Start Date :
November 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03797690
Start Date
November 2 2020
End Date
February 14 2029
Last Update
April 2 2025
Active Locations (4)
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1
Centre d'Imagerie Médicale Bachaumont Paris Centre
Paris, France, 75002
2
Hopital LARIBOISIERE - Radiologie
Paris, France, 75010
3
Hopital LARIBOISIERE - Rhumatologie
Paris, France, 75010
4
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Paris, France, 75016