Effectiveness of Percutaneous Needle Aponeurotomy

NCT03797690 | Recruiting

• 1 other identifier: P160903J
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dupuytren Disease of Finger

Keywords

Dupuytren's disease; Percutaneous needle aponeurotomy; Limited aponeurectomy; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Metacarpophalangeal joint contracture during passive extension

  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

  at 3 months after treatment

Secondary Outcomes (14)

• Metacarpophalangeal joint contractures during passive and active extension

  at 1 week, 1, 3, 12, 24 and 36 months after treatment

• Main metacarpophalangeal joint contracture during passive extension,

  at 36 months after treament

• The clinical success

  at 3 months after treament

• The recurrence

  at 12, 24 and 36 months after treament

• The interphalangeal joint contractures during passive and active extension

  at 1 week, 1, 3,12, 24 and 36 months after treatment

Study Arms (2)

Percutaneous needle aponeurotomy

EXPERIMENTAL

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.

Procedure: Percutaneous needle aponeurotomy

Open surgery with limited aponeurectomy

ACTIVE COMPARATOR

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).

Procedure: Open surgery with limited aponeurectomy

Interventions

Percutaneous needle aponeurotomy PROCEDURE

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

Percutaneous needle aponeurotomy

Open surgery with limited aponeurectomy PROCEDURE

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)

Open surgery with limited aponeurectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Centre d'Imagerie Médicale Bachaumont Paris Centre

Paris, 75002, France

ACTIVE NOT RECRUITING

Hopital LARIBOISIERE - Radiologie

Paris, 75010, France

ACTIVE NOT RECRUITING

Hopital LARIBOISIERE - Rhumatologie

Paris, 75010, France

RECRUITING

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

Paris, 75016, France

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johann BEAUDREUIL, PUPH

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johann BEAUDREUIL, PUPH

CONTACT

+33 1 49 95 88 28; johann.beaudruil@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary outcome (main metacarpophalangeal joint contracture during passive extension) will be assessed using low energy computed tomography before treatment, 3 months and 36 months after treatment for blinded assessment. Furthermore, in addition to the clinical follow-up, the patient will be followed by a blinded assessor. At each follow-up visits with the blinded assessor, patient will be asked to wear white opaque gloves to ensure the blinding for the treatment during assessment including the main outcome. Clinicians, nurses and patients will be instructed to the importance of avoiding communication about the treatment to the blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, non-inferiority PROBE (Prospective Randomized Open Blinded End-point) trial. Two groups (ratio 1:1) will be compared in this phase III pivotal study: experimental group versus control group.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: January 9, 2019
• Study Start: November 2, 2020
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): February 14, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

FR (4)