Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03797690 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Maladie de Dupuytren

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

novembre 2020

Date de fin

février 2029

Dernière mise à jour

03 avril 2025

Résumé

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.

Détail

Voir le détail 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 metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease. Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The 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. Practical procedure: Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Ambroise Paré	BEAUDREUIL Johann	En recrutement IDF	18/04/2025 07:56:28	Contacter
AP-HP - Hôpital Lariboisiere-Fernand Widal	BEAUDREUIL Johann	En recrutement IDF	18/04/2025 07:56:28	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
SCANNER BACHAUMONT PARIS CENTRE		Active, sans recrutement		Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur - 75016 - Paris - France	ERIC ROULOT, PH	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT03797690 - Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator (EFAPAD)

Informations générales
Etablissements
Critères
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