RecruitingNot ApplicableNCT03797690

Effectiveness of Percutaneous Needle Aponeurotomy

Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

120 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the effectiveness of percutaneous needle aponeurotomy (PNA) as a treatment for Dupuytren's disease — a hand condition where fibrous cords develop in the palm and pull the fingers into a bent position that can't be fully straightened. PNA is a minimally invasive office procedure where a doctor uses a small needle to break up these cords through the skin, without surgery. It offers a faster recovery than traditional open surgery but whether it's as effective long-term is still being studied. The study focuses on adults with a confirmed Dupuytren's contracture affecting the main knuckle joint (metacarpophalangeal joint) of at least 20 degrees. Participants will have their hand function and contracture measurements tracked before and after the procedure. You may be eligible if: - You are 18 or older - You have a confirmed Dupuytren's disease with a palpable fibrous cord - You have at least 20 degrees of flexion contracture at a metacarpophalangeal joint - You are covered by social security You may NOT be eligible if: - You have other significant hand conditions like inflammatory arthritis or pain at the affected joint - You have had previous surgery on the same hand that limits movement - You are pregnant or breastfeeding - You are currently enrolled in another interventional trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPercutaneous needle aponeurotomy

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

PROCEDUREOpen surgery with limited aponeurectomy

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)


Locations(4)

Centre d'Imagerie Médicale Bachaumont Paris Centre

Paris, France

Hopital LARIBOISIERE - Radiologie

Paris, France

Hopital LARIBOISIERE - Rhumatologie

Paris, France

JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur

Paris, France

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NCT03797690


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