Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY)

April 20, 2026 updated by: Elsan

Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).

Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.

Various medical and surgical treatments are available.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Among these treatments, none to date can eliminate recurrences, which are still too frequent.

Open aponeurectomy (consisting of surgical curettage of the fibrotic cords) remains for the moment the reference technique for treating Dupuytren's disease, with recurrences (between 12 and 39%), but less frequent than the needle technique (50 to 85%).

Could the addition of adipose tissue in the resection areas of Dupytren's fibrosis reduce the rate of recurrence (by the inhibitory action of ADCs on myofibroblasts) in addition to reconstructing the hypodermis in the cavity left by the resection of the cords and improving the quality of the scars? The investigators insist on the fact that this is a homotopic and homologous adipose tissue graft, in closed circuit without denaturation or adjuvant products.

Since, to our knowledge, no other team has used "lipofilling" as an adjuvant treatment to the open resection technique of Dupuytren's cords (aponeurectomy), the investigators first conducted a clinical feasibility and safety study on 70 patients between 2012 and 2017 (currently being published by Springer Editions).

The investigators now wish to conduct a prospective comparative study between patients operated by aponeurectomy WITH (experimental group) and WITHOUT (control group) addition of autologous adipose tissue in the resection areas of Dupuytren's cords.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Pessac, France, 33600
        • Recruiting
        • Institut Aquitain de la Main
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elias Sawaya, MD
      • Saint-Herblain, France, 44800
        • Recruiting
        • Santé Atlantique ELSAN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated
  • Indication of a surgery by aponeurectomy
  • Skin pinch of the posterior aspect of the arm of more than 1cm
  • Affiliation to a social security system
  • Patient informed of the study and having given informed consent

Exclusion Criteria:

  • Previous surgery of any kind for Dupuytren's disease
  • Involvement on the thumb only
  • Need for a total skin graft or a pedicle flap on all the rays to be treated
  • Active autoimmune disease
  • Previous treatment with collagenase
  • Pregnant and breastfeeding women
  • Patient under legal protection
  • Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aponeurectomy with grafting
The experimental group evaluates the aponeurectomy associated with adipose tissue grafting.
Procedure: Aponeurectomy with grafting

The lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system.

The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions.
Active Comparator: Aponeurectomy alone
The control group evaluates the aponeurectomy alone.
Procedure: Aponeurectomy alone
The patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2-year recurrence rate of Dupuytren's disease
Time Frame: 2 Years after intervention
Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint.
2 Years after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3-year recurrence rate in both groups
Time Frame: 3 Years after intervention
Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 3 years post-op compared to 6 weeks post-op
3 Years after intervention
5-year recurrence rate in both groups
Time Frame: 5 Years after intervention
Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 5 years post-op compared to 6 weeks post-op
5 Years after intervention
Comparison of the appearance of scars in both groups
Time Frame: 1 Year after intervention
Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales.
1 Year after intervention
Comparison of the appearance of scars in both groups
Time Frame: 2 Years after intervention
Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales.
2 Years after intervention
Comparison of the complication rates in both groups
Time Frame: 1 Week after intervention
Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage.
1 Week after intervention
Comparison of the complication rates in both groups
Time Frame: 6 Weeks after intervention
Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage.
6 Weeks after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time Frame: 1 Year after intervention
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
1 Year after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time Frame: 2 Years after intervention
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
2 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time Frame: 3 Years after intervention
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
3 Years after intervention
Comparison of the rate of occurrence of algodystrophy, regardless of cause
Time Frame: 5 Years after intervention
Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest.
5 Years after intervention
Comparison of the effect on quality of life in both groups
Time Frame: 6 Weeks after intervention
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
6 Weeks after intervention
Comparison of the effect on quality of life in both groups
Time Frame: 1 Year after intervention
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
1 Year after intervention
Comparison of the effect on quality of life in both groups
Time Frame: 2 Years after intervention
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
2 Years after intervention
Comparison of the effect on quality of life in both groups
Time Frame: 5 Years after intervention
Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function.
5 Years after intervention
Evaluation of the primary endpoint on the second hand operated on.
Time Frame: Within five years after intervention

The surgery being done with or without fat according to the treatment of the 1st randomized hand (cross-over scheme).

Data collection for the second surgery only if it occurs between the 1st hand surgery and the patient's protocol discharge.
Within five years after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elsan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elias SAWAYA, MD, Institut Aquitain de la Main

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REMEDY
  • 2020-A03214-35 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dupuytren's Disease

Clinical Trials on Aponeurectomy with grafting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings