Clinical trial NCT03797690: Effectiveness of Percutaneous Needle Aponeurotomy
Official title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren Disease of Finger
Keywords: Dupuytren's disease
Percutaneous needle aponeurotomy
Limited aponeurectomy
Randomized trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Metacarpophalangeal joint contracture during passive extension
timeFrame: at 3 months after treatment
Secondary outcomes:
measure: Metacarpophalangeal joint contractures during passive and active extension
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: Main metacarpophalangeal joint contracture during passive extension,
timeFrame: at 36 months after treament
measure: The clinical success
timeFrame: at 3 months after treament
measure: The recurrence
timeFrame: at 12, 24 and 36 months after treament
measure: The interphalangeal joint contractures during passive and active extension
timeFrame: at 1 week, 1, 3,12, 24 and 36 months after treatment
measure: The 70% improvement from baseline of the flexion contracture
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: The functional limitation using Quick DASH questionnaire
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: The URAM scale
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: The patient satisfaction on a 0-100 mm visual analog scale
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
measure: The number of secondary and repeated treatments
timeFrame: at 12, 24 and 36 months after treatment
measure: Complications and adverse events for primary treatment
timeFrame: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;
measure: Complications and adverse events for secondary treatment
timeFrame: at the treatment time, at 12, 24 and 36 months;
measure: The post-interventional pain and needs
timeFrame: at 1 week, 1, 3, 12, 24 and 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Imagerie Médicale Bachaumont Paris Centre
city: Paris
country: France
facility: Hopital LARIBOISIERE - Radiologie
city: Paris
country: France
facility: Hopital LARIBOISIERE - Rhumatologie
city: Paris
country: France
facility: JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Study officials:
affiliation: APHP
name: Johann BEAUDREUIL, PUPH
role: PRINCIPAL_INVESTIGATOR
References: