Effectiveness of Percutaneous Needle Aponeurotomy
ConditionDupuytren Disease of Finger
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous needle aponeurotomy
Procedure/SurgeryIt 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
Procedure/SurgeryIt 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)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Percutaneous needle aponeurotomyExperimental treatment 1 intervention
Group B: Open surgery with limited aponeurectomyActive comparator 1 intervention
Trial outcomes
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
Time frame
at 3 months after treatmentSecondary outcomes
1
Metacarpophalangeal joint contractures during passive and active extension
Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.
Time frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment2
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).
Time frame
at 36 months after treament3
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.
Time frame
at 3 months after treament4
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.
Time frame
at 12, 24 and 36 months after treamentSponsors and contacts
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Source ClinicalTrials.gov