Effectiveness of Percutaneous Needle Aponeurotomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dupuytren Disease of Finger

Intervention / Treatment
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* Procedure: Percutaneous needle aponeurotomy
* Procedure: Open surgery with limited aponeurectomy


Participation Criteria
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Eligibility Criteria
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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 open surgery of the hand for any reason 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous needle aponeurotomy<br>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<br>* 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<br>|
| Active Comparator: Open surgery with limited aponeurectomy<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metacarpophalangeal joint contractures during passive and active extension | Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment. | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| Main 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). | at 36 months after treament | 
| The clinical success | The clinical success is defined as the reduction of flexum to within 0 to 5° during passive extension, using clinical goniometry, for the main metacarpophalangeal joint); Patient will wear white opac gloves to ensure blinded assessment. | at 3 months after treament | 
| The recurrence | The recurrence is defined as the flexum progression of 20°, during passive extension, using clinical goniometry, after clinical success. Patient will wear white opac gloves to ensure blinded assessment. | at 12, 24 and 36 months after treament | 
| The interphalangeal joint contractures during passive and active extension | Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment. | at 1 week, 1, 3,12, 24 and 36 months after treatment | 
| The 70% improvement from baseline of the flexion contracture | The flexion contracture of each treated joint, during passive extension will be assessed by a blinded assessor (Patient will wear white opac gloves). - Flexion contracture in degrees using goniometry reported as follows: ray Number; metacarpophalangeal angle; interphalangeal angle | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints | The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints will be assessed by a blinded assessor (Patient will wear white opac gloves). | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| The functional limitation using Quick DASH questionnaire | The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability). | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| The URAM scale | The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability). | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| The patient satisfaction on a 0-100 mm visual analog scale | The assessor will ask the patient the following question: How would you rate satisfaction about the treatment you underwent in the study? Patients will be asked to mark the level of their satisfaction on a l00-mm, nonhatched VAS scale marked at one end as not satisfied and at the other as completely satisfied'' | at 1 week, 1, 3, 12, 24 and 36 months after treatment | 
| The number of secondary and repeated treatments | The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor. | at 12, 24 and 36 months after treatment | 
| Complications and adverse events for primary treatment | The number and the types of complications and adverse events for primary open surgery and first line percutaneous needle aponeurotomy will be collected by an unblinded assessor. | at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months; | 
| Complications and adverse events for secondary treatment | The number and the types of complications and adverse events for secondary open surgery and percutaneous needle aponeurotomy will be collected by an unblinded assessor. | at the treatment time, at 12, 24 and 36 months; | 
| The post-interventional pain and needs | The post-interventional pain and needs of nursing, splinting, medication, physiotherapy,sick leave, time return to regular activities using a patient diary. These datas will be collected by the unblinded assessor. | at 1 week, 1, 3, 12, 24 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial