Effectiveness of Percutaneous Needle Aponeurotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous needle aponeurotomy, Open surgery with limited aponeurectomy.
- Who it may be relevant to
- Registry conditions: Dupuytren Disease of Finger. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Overview
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.
Detailed description
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.
Interventions
- Procedure 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 - 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)
Primary outcome measures
- Metacarpophalangeal joint contracture during passive extension [Time frame: at 3 months after treatment]
Secondary outcome measures (12)
- Metacarpophalangeal joint contractures during passive and active extension [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- Main metacarpophalangeal joint contracture during passive extension, [Time frame: at 36 months after treament]
- The clinical success [Time frame: at 3 months after treament]
- The recurrence [Time frame: at 12, 24 and 36 months after treament]
- The interphalangeal joint contractures during passive and active extension [Time frame: at 1 week, 1, 3,12, 24 and 36 months after treatment]
- The 70% improvement from baseline of the flexion contracture [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- The functional limitation using Quick DASH questionnaire [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- The URAM scale [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- The patient satisfaction on a 0-100 mm visual analog scale [Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment]
- The number of secondary and repeated treatments [Time frame: at 12, 24 and 36 months after treatment]
- Complications and adverse events for primary treatment [Time frame: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 4 centers
- Centre d'Imagerie Médicale Bachaumont Paris Centre — Paris
- Hopital LARIBOISIERE - Radiologie — Paris
- Hopital LARIBOISIERE - Rhumatologie — Paris
- JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur — Paris
Identifiers
NCT: NCT03797690 · P160903J