Comparing a minimally invasive procedure to open surgery for Dupuytren's disease
Official title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
Run by Assistance Publique - Hôpitaux de Paris · NCT03797690 · Data updated 2026-11-12
This study is testing whether a less invasive needle procedure can effectively treat hand contractures from Dupuytren's disease as well as traditional open surgery for adults with this condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Paris and 3 other locations) |
| Status | Recruiting |
| Started | November 2, 2020 |
| Main results expected | March 14, 2027 |
| Study ends | February 14, 2029 |
| Registry record updated | April 2, 2025 |
| Trial ID | NCT03797690 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with palpable Dupuytren's disease and a specific degree of flexion contracture in their fingers.
✕Probably not a fit
Patients with other musculoskeletal disorders of the hand or previous surgeries that limit finger mobility may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of percutaneous needle aponeurotomy compared to open surgery for treating flexion contracture caused by Dupuytren's disease. The study aims to determine if the minimally invasive procedure is as effective and safe as traditional surgery, potentially reducing the need for more invasive interventions. Participants will be adults with diagnosed Dupuytren's disease who have specific flexion contractures. The trial will assess outcomes related to efficacy, safety, and cost-effectiveness.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with Dupuytren's disease, leading to quicker recovery times and reduced healthcare costs.
How similar studies have gone: Previous studies have shown promising results for percutaneous needle aponeurotomy, suggesting it could be a viable alternative to open surgery.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hopital LARIBOISIERE - Rhumatologie
Paris, France Recruiting -
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Paris, France Recruiting -
Centre d'Imagerie Médicale Bachaumont Paris Centre
Paris, France Active not recruiting -
Hopital LARIBOISIERE - Radiologie
Paris, France Active not recruiting
Study contacts
- Principal investigator: Johann BEAUDREUIL, PUPH — Aphp
- Study coordinator: Johann BEAUDREUIL, PUPH
- Email: johann.beaudruil@aphp.fr
- Phone: +33 1 49 95 88 28
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CNT201 collagenase injection for Dupuytren’s: safety and signals of efficacy in adults
A randomized, placebo-controlled study will test CNT201 injections to see if they are safe and help improve finger contractures in adults with Dupuytren’s disease.
-
Evaluating post-surgery radiation treatment for Dupuytren's disease
This study is testing whether adding radiation treatment after surgery for Dupuytren's disease can help improve hand function and reduce symptoms for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.