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Effectiveness of Percutaneous Needle Aponeurotomy (EFAPAD)

Primary Purpose

Dupuytren Disease of Finger

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous needle aponeurotomy
Open surgery with limited aponeurectomy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren Disease of Finger focused on measuring Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d'Imagerie Médicale Bachaumont Paris Centre
  • Hopital LARIBOISIERE - Radiologie
  • Hopital LARIBOISIERE - RhumatologieRecruiting
  • JOUVENET - Orthopédie, chirurgie de la main et du membre supérieurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Percutaneous needle aponeurotomy

Open surgery with limited aponeurectomy

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Metacarpophalangeal joint contractures during passive and active extension
Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.
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).
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.
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.
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.
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
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).
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).
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).
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''
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.
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.
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.
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.

Full Information

First Posted
June 25, 2018
Last Updated
December 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03797690
Brief Title
Effectiveness of Percutaneous Needle Aponeurotomy
Acronym
EFAPAD
Official Title
Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
March 14, 2025 (Anticipated)
Study Completion Date
December 14, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Disease of Finger
Keywords
Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous needle aponeurotomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Open surgery with limited aponeurectomy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Percutaneous needle aponeurotomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Open surgery with limited aponeurectomy
Intervention Description
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 Measure Information:
Title
Metacarpophalangeal joint contracture during passive extension
Description
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 treatment
Secondary Outcome Measure Information:
Title
Metacarpophalangeal joint contractures during passive and active extension
Description
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 treatment
Title
Main metacarpophalangeal joint contracture during passive extension,
Description
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 treament
Title
The clinical success
Description
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 treament
Title
The recurrence
Description
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 treament
Title
The interphalangeal joint contractures during passive and active extension
Description
Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment.
Time Frame
at 1 week, 1, 3,12, 24 and 36 months after treatment
Title
The 70% improvement from baseline of the flexion contracture
Description
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
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment
Title
The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints
Description
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).
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment
Title
The functional limitation using Quick DASH questionnaire
Description
The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability).
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment
Title
The URAM scale
Description
The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability).
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment
Title
The patient satisfaction on a 0-100 mm visual analog scale
Description
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''
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months after treatment
Title
The number of secondary and repeated treatments
Description
The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor.
Time Frame
at 12, 24 and 36 months after treatment
Title
Complications and adverse events for primary treatment
Description
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.
Time Frame
at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;
Title
Complications and adverse events for secondary treatment
Description
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.
Time Frame
at the treatment time, at 12, 24 and 36 months;
Title
The post-interventional pain and needs
Description
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.
Time Frame
at 1 week, 1, 3, 12, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johann BEAUDREUIL, PUPH
Phone
+33 1 49 95 88 28
Email
johann.beaudruil@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann BEAUDREUIL, PUPH
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'Imagerie Médicale Bachaumont Paris Centre
City
Paris
ZIP/Postal Code
75002
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital LARIBOISIERE - Radiologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital LARIBOISIERE - Rhumatologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann BEAUDREUIL, PUPH
Phone
01 49 95 88 28
Email
johann.beaudreuil@aphp.fr
Facility Name
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
City
Paris
ZIP/Postal Code
75016
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ERIC ROULOT, PH
Phone
01 42 15 42 33
Email
secretaire.roulot@gmail.com

12. IPD Sharing Statement

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Effectiveness of Percutaneous Needle Aponeurotomy

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