An interventional study of Surgical treatment in Dupuytren's Disease and Surgical Incision, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy.The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.
Dupuytren's disease is characterised by retractile fibrosis of the superficial palmar aponeurosis that can result in irreversible flexing of the fingers and long-term disability. The treatment of Dupuytren's disease, whether medical or surgical, remains symptomatic. It is based in Europe on percutaneous needle aponeurotomy and surgical aponeurectomy. Its objectives are the reduction of the deformity of the fingers in flexum, and that of the incapacity that generates the illness. Percutaneous needle aponeurotomy for Dupuytren's disease was developed by Jean-Luc Lermusiaux in 1972 in the Rheumatology Department of the Lariboisière Hospital in Paris. Its efficiency, its tolerance, its simplicity, its low cost and the possibility of repeating it make it a benchmark treatment. Percutaneous needle aponeurotomy is, for many, if the existence of this technique is known and understood, the first-line treatment of Dupuytren's disease.
As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy. The safety and efficacy of the surgery was evaluated in the context of a first-line treatment of Dupuytren's disease. The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.
81 studies on the registry are indexed under Dupuytren Contracture; 17 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 60 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 204 studies on the registry; 97 are open to participants now.
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Exclusion Criteria:
Protected adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, Pregnant, lactating or parturient women, Hospitalised without consent.
9- Patient who has already undergone the surgical procedure under study on one of the two hands in the last 12 months or patient requiring surgery for the second hand in the next 14 months.
Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
Procedure: Surgical treatment
Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously
joint deformity
Primary end point: joint deformity of each treated joint at 3 months.• The development of the degree of joint extension malalignment at 3 months will be described both by the relative difference and by the absolute difference between the measurements at V0 and V3, overall and for each modality of the known prognostic factors: joint types (MCP versus PIP), age at onset of disease (\<50 years versus \>= 50 years), initial severity of disease.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2019 (actual). Primary completion is estimated for Jun 2020, 13 months after the start.
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This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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