An interventional study of Vivosorb in Dupuytren Contracture and Dupuytren Disease of Palm and Finger, sponsored by prof. dr. Ilse Degreef. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by prof. dr. Ilse Degreef · Not applicable, Interventional, and Treatment
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Dupuytren's disease is a progressive fibroproliferative condition of the hand which progresses in 20% of patients into a serious condition. In Flanders, Dupuytren's disease was found to be present in 32% of the population over 50 years.
In severe flexion contracture finger deformity due to Dupuytren's disease, functional loss of the finger (often the fourth or fifth digit) is significant.
Surgery remains the most efficient treatment for the correction of flexion deformities. Minimal invasive surgery with the creation of firebreaks for the fibrous strands causing this disease, withholds fast recovery. However, recurrence after surgery is not rare with numbers varying from 30 to 70% depending on fibrosis diathesis score of Abe, severity of the deformation and follow-up period.
Numerous surgical techniques have been used for Dupuytren disease, ranging from minimally invasive surgery to subtotal preaxial amputation with skin grafting.3 In this study a well-known technique faciectomie will be performed. During this surgery a device will be inserted called VIVOSORB® VIVOSORB® is a flexible bioresorbable polymer film which is designed to separate opposing tissues throughout the critical healing process. It is very flexible facilitating the surgeon to optimally position the sheet during surgery. It is made of 100% synthetic bioresorbable material and can be used in a variety of soft tissue surgery applications. VIVOSORB® provides a barrier function enabling the tissue to regenerate without interconnective attachment.
In the past cellulose, a biologic inert implant, was used for augmenting the effect of the surgical firebreaks . Cellulose has been proven to improve outcome. Nowadays, cellulose is not available for use during faciectomie surgery, since medical production has been ceased. VIVOSORB® can be a valid alternative.
Patient scores will be evaluated:
78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →This is the only study on the registry with prof. dr. Ilse Degreef as lead sponsor.
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Exclusion Criteria:
Only arm in study
Device: Vivosorb
Resorbable implant device
Total Passive Extension Deficit (TPED)
TPED of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints of each finger will be measured with an goniometer by an orthopaedic surgeon (the active and passive range of motion flexion and extension).
Time frame: 2 years post-surgery
DASH score
This questionnaire asks the patient about their symptoms as well as their ability to perform certain activities. It's a 30 item questionnaire scored on a Likert scale from 1 (best outcome) to 5 (worst outcome). Maximum total DASH score=100. Higher DASH score indicates worse situation.
Time frame: 2 years post-surgery
VAS pain & satisfaction
On a 10 point scale the patients will score the pain of the hand and the level of satisfaction with the current state of their finger. 0=no pain, 10=worst pain; 0=not satisfied, 10=very satisfied
Time frame: 2 years post-surgery
EQ-5D-3L
Standardised instrument for use as a measure of health outcome
Time frame: 2 years post-surgery
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Dec 2024, 72 months after the start.
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This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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