Prognostic Profile of Dupuytren's Disease: a Cohort Study (PRODUCT)

NCT07353060 | Not Yet Recruiting

• 1 other identifier: 2024-A00473-44
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

Dupuytren's disease is characterized by retractile fibrosis of the superficial palmar aponeurosis, which can lead to irreversible flexion contractures of the fingers and lasting functional impairment. Widespread throughout the world, it has a particularly high prevalence in northern European countries. This has been estimated at between 3.5% and 11% in England and Denmark. This prevalence is expected to increase over time due to the aging population. Risk factors for the disease include age, male sex, heredity, diabetes, smoking, and alcohol consumption. The resulting disability is not spontaneously reversible. It affects various aspects of daily life, most notably personal care, nutrition, and social interaction. Treatment for Dupuytren's disease, whether medical or surgical, remains symptomatic to date and does not preclude the possibility of recurrence. In France, it is based on percutaneous needle aponeurotomy and surgical aponeurectomy. Its objectives are to reduce the flexion contracture of the fingers and the functional disability caused by the disease. Enzymatic aponeurosis with collagenase is also possible, but it is less well tolerated than percutaneous needle aponeurotomy. It is more expensive and not covered by health insurance. The widespread adoption of a medical-surgical strategy that positions percutaneous needle aponeurotomy as the first-line treatment could improve the acceptability of Dupuytren's disease treatment and significantly reduce its cost to healthcare systems. However, the impact of this strategy depends on the extent to which second-line surgery is required. This use has been little studied. The proportion of patients requiring surgical treatment after percutaneous needle aponeurotomy is estimated to be 10 to 18%. These data are based on small sample sizes observed over varying follow-up periods. They need to be verified in large populations using a prospective study. Moreover, the factors associated with the need for surgery after percutaneous needle ablation for Dupuytren's disease are currently poorly understood. Understanding these factors would be beneficial for optimizing medical and surgical management. It could allow for better tailoring of treatment options to the patient's individual profile.

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• Use of surgery (yes/no)

  Use of surgery within 3 years following treatment by percutaneous needle aponeurotomy for Dupuytren's disease. the result is yes or not.

  3 years

Study Arms (1)

Patient with Dupuytren's disease

EXPERIMENTAL

Treatment by percutaneous needle aponeurotomy

Other: Questionnaires; Other: Clinical examination

Interventions

Questionnaires OTHER

The functional assessment of patients will be carried out using the Quick DASH, URAM and Southampton scores.

Patient with Dupuytren's disease

Clinical examination OTHER

A clinical examination of the patient with assessment of the morphological impact by quantifying the deformity of the fingers in flexion using angular measurement and the Tubiana score

Patient with Dupuytren's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, male or female, over 18 years of age
• Patient with Dupuytren's disease confirmed by clinical examination: nodule or cord arising from the superficial palmar aponeurosis, visible or palpable
• Aponeurotic cord causing an MCP or PIP joint flexion contracture of at least 20°
• Indication for percutaneous needle ablation (flexion contracture of at least 20°, functionally impaired according to the patient)
• Acceptance of percutaneous needle ablation by the patient
• Patient affiliated with or covered by a social security scheme
• Patient having been informed and having signed a free and informed written consent
• Negative urine pregnancy test for women of childbearing age

You may not qualify if:

• Minor patient,
• Patient with another condition, infection, or wound of the hand,
• Patient participating in another clinical trial,
• Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision,
• Person unable to express their consent,
• Pregnant, breastfeeding, or parturient woman

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Jean-François Oudet, M

CONTACT

0033683346567; jf.oudet@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 4, 2030
• Study Completion (Estimated): February 4, 2031
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (1)