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Clinical Trials in France / NCT03797690
Recruiting Not applicable

Effectiveness of Percutaneous Needle Aponeurotomy

NCT03797690 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2020-11-02
Last updated
2025-04-02

Condition(s) studied

Dupuytren Disease of Finger

Investigational drug(s) / intervention(s)

Percutaneous needle aponeurotomyOpen surgery with limited aponeurectomy

Percutaneous 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

Open 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)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Metacarpophalangeal joint contracture during passive extension — at 3 months after treatment
    Expressed in degrees, using low energy computed tomography for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). Baseline will be Metacarpophalangeal joint contracture during passive extension the day of the treatment, before any treatment

Trial sites (4)

FacilityCityRegionStatus
Centre d'Imagerie Médicale Bachaumont Paris Centre Paris France Active Not Recruiting
Hopital LARIBOISIERE - Radiologie Paris France Active Not Recruiting
Hopital LARIBOISIERE - Rhumatologie Paris France Recruiting
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03797690 on ClinicalTrials.gov ↗ ← All trials in France