Actively Recruiting
Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial with Surgery as Comparator
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02
120
Participants Needed
4
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether percutaneous needle aponeurotomy is not less effective than open surgery with aponeurectomy for treating flexion contracture caused by Dupuytren's disease. This condition involves fibrosis of the palmar aponeurosis, leading to disabling joint contractures in the fingers. The study aims to determine if the minimally invasive needle procedure can reduce the need for open surgery while maintaining suitable safety and efficacy. Participants will be randomly assigned to receive either percutaneous needle aponeurotomy, which involves cutting the fibrotic cord with a needle under local anesthesia in one to three outpatient sessions, or open surgery with excision of the fibrotic tissue performed under regional anesthesia during a short hospital stay. Postoperative care including analgesics, splints, nursing, and physiotherapy is provided after surgery. Treatment completion is defined as the last needle session or stitch removal after surgery. Participants will be followed up at 1 week, 1, 3, 12, 24, and 36 months after treatment. Assessments include measuring joint contractures, range of motion, functional limitation questionnaires, patient satisfaction, complications, and recurrence. Efficacy assessments are conducted in a blinded manner, while complications are evaluated openly. The primary outcome is the degree of metacarpophalangeal joint contracture during passive extension at 3 months post-treatment.
CONDITIONS
Brief 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
- Signed written informed consent
- Affiliated to social security system
You will not qualify if you...
- Other musculoskeletal disorders of the hand besides Dupuytren's disease, including inflammatory rheumatic diseases or joint pain
- Previous surgery on the treated hand causing functional or finger mobility limitation
- Any other pathological condition or limited finger motion in the treated finger
- Psychiatric conditions preventing evaluation, vulnerable persons, or legal incapacity
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks depending on treatment sessions or until surgical treatment completion
Participants receive either percutaneous needle aponeurotomy or open surgery to treat Dupuytren's disease. Percutaneous needle aponeurotomy involves cutting the fibrotic cord with a needle under local anesthesia and may require one to three sessions spaced at least one week apart, performed in outpatient settings. Open surgery involves excision of the fibrotic aponeurosis under loco-regional anesthesia with a short hospitalization (1 day stay) and post-operative care.
1 to 3 outpatient procedure sessions for needle aponeurotomy or 1 hospitalization day for open surgery
Duration - 36 months
Participants are monitored for treatment efficacy, complications, and recovery with visits at 1 week, 1 month, 3 months, 12 months, 24 months, and 36 months after treatment.
6 visits post-treatment (1 week, 1, 3, 12, 24, and 36 months)
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
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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