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

NCT03741764 | Unknown

• 1 other identifier: S61390
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dupuytren Contracture; Dupuytren Disease of Palm and Finger

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years post-surgery

Secondary Outcomes (3)

• DASH score

  2 years post-surgery

• VAS pain & satisfaction

  2 years post-surgery

• EQ-5D-3L

  2 years post-surgery

Study Arms (1)

Vivosorb

OTHER

Only arm in study

Device: Vivosorb

Interventions

Vivosorb DEVICE

Resorbable implant device

Vivosorb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject is younger than 18
• Subject is not a good candidate for the study based on Investigator opinion

Sponsors & Collaborators

• prof. dr. Ilse Degreef: lead

Study Sites (1)

UZ Leuven, campus Pellenberg

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ilse Degreef, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Ilse Degreef

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 15, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)