Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 3:49 AM
Study NCT ID:
NCT07353060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Profile of Dupuytren's Disease: a Cohort Study (PRODUCT)
Sponsor:
Ramsay Générale de Santé
Organization:
Study Overview
Official Title:
Prognostic Profile of Dupuytren's Disease: a Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRODUCT
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.
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.
Detailed Description:
Percutaneous needle aponeurotomy for Dupuytren's disease was developed by Jean-Luc Lermusiaux in 1972, in the Rheumatology Department of Lariboisière Hospital in Paris. Its efficacy, tolerability, simplicity, and low cost make it a standard treatment. For many, provided they are informed about the existence of this technique and master it, it is the first-line treatment for Dupuytren's disease. Within the framework of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease therefore appears as a second-line treatment indicated in cases of failure after percutaneous treatment. This positioning is, however, not universally accepted. Surgery remains the most common treatment for Dupuytren's disease today.
The main objective of the study is to describe the proportion of patients requiring surgery within 3 years of treatment by percutaneous needle aponeurotomy for Dupuytren's disease
The main objective of the study is to describe the proportion of patients requiring surgery within 3 years of treatment by percutaneous needle aponeurotomy for Dupuytren's disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: