Effectiveness of Percutaneous Needle Aponeurotomy (EFAPAD)
Dupuytren Disease of Finger
About this trial
This is an interventional treatment trial for Dupuytren Disease of Finger focused on measuring Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 open surgery of the hand for any reason
- 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
Sites / Locations
- Centre d'Imagerie Médicale Bachaumont Paris Centre
- Hopital LARIBOISIERE - Radiologie
- Hopital LARIBOISIERE - RhumatologieRecruiting
- JOUVENET - Orthopédie, chirurgie de la main et du membre supérieurRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Percutaneous needle aponeurotomy
Open surgery with limited aponeurectomy
It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure. End of treatment will be considered as the last session of needle aponeurotomy.
It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment).