NCT03797690 Effectiveness of Percutaneous Needle Aponeurotomy
| NCT ID | NCT03797690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Dupuytren Disease of Finger |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-11-02 |
| Primary Completion | 2027-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-11-02 with a primary completion date of 2027-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Johann BEAUDREUIL, PUPH
PRINCIPAL INVESTIGATOR
APHP
Frequently Asked Questions
Who can join the NCT03797690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dupuytren Disease of Finger. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03797690 currently recruiting?
Yes, NCT03797690 is actively recruiting participants. Contact the research team at johann.beaudruil@aphp.fr for enrollment information.
Where is the NCT03797690 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France, Paris, France.
Who is sponsoring the NCT03797690 clinical trial?
NCT03797690 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Johann BEAUDREUIL, PUPH at APHP. The trial plans to enroll 120 participants.