Comparing a minimally invasive procedure to open surgery for Dupuytren's disease
Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT03797690 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other musculoskeletal disorders of the hand or previous surgeries that limit finger mobility may not benefit from this study.
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 performed: Previous studies have shown promising results for percutaneous needle aponeurotomy, suggesting it could be a viable alternative to open surgery.
Eligibility criteria
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 this trial is running
Paris and 3 other locations
- Centre d'Imagerie Médicale Bachaumont Paris Centre — Paris, France (Active_not_recruiting)
- Hopital LARIBOISIERE - Radiologie — Paris, France (Active_not_recruiting)
- Hopital LARIBOISIERE - Rhumatologie — Paris, France (Recruiting)
- JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur — Paris, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.