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Effectiveness of Percutaneous Needle Aponeurotomy (EFAPAD)

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ClinicalTrials.gov Identifier: NCT03797690
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Dupuytren Disease of Finger Procedure: Percutaneous needle aponeurotomy Procedure: Open surgery with limited aponeurectomy Not Applicable

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 four 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 11, 2021
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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. End of treatment will be considered as the last session of needle aponeurotomy.
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

Active Comparator: 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). 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
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 :
  1. Metacarpophalangeal joint contracture during passive extension [ Time Frame: at 3 months after treatment ]
    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 :
  1. Metacarpophalangeal joint contractures during passive and active extension [ Time Frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment ]
    Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.

  2. Main metacarpophalangeal joint contracture during passive extension, [ Time Frame: at 36 months after treament ]
    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).

  3. The clinical success [ Time Frame: at 3 months after treament ]
    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.

  4. The recurrence [ Time Frame: at 12, 24 and 36 months after treament ]
    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.

  5. The interphalangeal joint contractures during passive and active extension [ Time Frame: at 1 week, 1, 3,12, 24 and 36 months after treatment ]
    Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment.

  6. The 70% improvement from baseline of the flexion contracture [ Time Frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment ]
    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

  7. 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 active range of motion of metacarpophalangeal and proximal interphalangeal treated joints will be assessed by a blinded assessor (Patient will wear white opac gloves).

  8. The functional limitation using Quick DASH questionnaire [ Time Frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment ]
    The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability).

  9. The URAM scale [ Time Frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment ]
    The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability).

  10. 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 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''

  11. The number of secondary and repeated surgeries [ Time Frame: at 12, 24 and 36 months after treatment ]
    The number of secondary (after percutaneous needle aponeurotomy) or repeated (after first open surgery) open surgery will be recorded by the unblinded assessor.

  12. Complications and adverse events for primary treatment [ Time Frame: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months; ]
    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.

  13. Complications and adverse events for secondary treatment [ Time Frame: at the treatment time, at 12, 24 and 36 months; ]
    The number and the types of complications and adverse events for secondary open surgery will be collected by an unblinded assessor.

  14. The post-interventional pain and needs [ Time Frame: at 1 week, 1, 3, 12, 24 and 36 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03797690     History of Changes
Other Study ID Numbers: P160903J
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dupuytren's disease
Percutaneous needle aponeurotomy
Limited aponeurectomy
Randomized trial

Additional relevant MeSH terms:
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Dupuytren Contracture
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs