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NOT YET RECRUITING
NCT07353060
NA

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

Sponsor: Ramsay Générale de Santé

View on ClinicalTrials.gov

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.

Official title: Prognostic Profile of Dupuytren's Disease: a Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

305

Start Date

2026-02-04

Completion Date

2031-02-04

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

OTHER

Questionnaires

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

OTHER

Clinical examination

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

Locations (1)

Hôpital Lariboisière

Paris, France