Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device

Launched by PROF. DR. ILSE DEGREEF · Nov 12, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to treat Dupuytren's disease, which causes fingers to bend towards the palm and can lead to significant loss of function. The study focuses on using a type of minimally invasive surgery called fasciectomy, where the surgeon removes the thickened tissue causing the problem. During this procedure, a special device called VIVOSORB® will be placed in the hand. VIVOSORB® is a flexible material that helps keep the tissues apart while they heal, allowing for better recovery. This trial is important because it aims to find a better way to help people with severe finger deformities from Dupuytren's disease, particularly since a previously used material is no longer available.

To participate in the trial, individuals must be at least 18 years old, have been diagnosed with Dupuytren's disease, and have a severe bending of their fingers. They should also meet certain medical criteria that indicate their condition is advanced. Participants will receive treatment at UZ Leuven and will need to sign a consent form agreeing to take part in the study. This trial is currently active but not recruiting new participants, meaning they are not looking for additional volunteers at this time. If you're considering participation in a future study or have questions, discussing with your healthcare provider is a good step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is diagnosed with the disease of Dupuytren
• • Subject suffers from a severe flexion deformity of the finger(s)
• • Stage of Dupuytren's disease ≥ 3 as introduced by Tubiana4
• • Dupuytren's patients with risk score D of Abe \> 4 \[5\]
• • Subject is 18 years or older
• • Subject is willing to sign and date an IRB/EC-approved consent form
• • Subject receives treatment in UZ Leuven
• Exclusion Criteria:
• • Subject is younger than 18
• • Subject is not a good candidate for the study based on Investigator opinion