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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dupuytren Contracture; Dupuytren Disease of Palm and Finger
• Intervention / Treatment: Device: Vivosorb

Detailed Description

• Trial objectives The objective of this study is to establish if this device is a viable option for treating finger deformity caused by Dupuytren's disease. The main goal is to evaluate the efficacy and performance of this flexible bioresorbable polymer film (VIVOSORB®) Expected outcome is significant correction of the finger extension lack with preserved active finger flexion, without amputation risk or neurovascular damage due to more invasive surgery.
• Primary endpoints The device will be considered efficient if the pre-operative lack of finger extension (TPED) compared to the extension at two years post-operative improves by 46°.
• Secondary endpoints

Patient scores will be evaluated:

• Dash score
• EQ-5D-3L
• VAS pain & satisfaction Amputation is a final endpoint for this study. Secondary a comparison will be made between the population of this study and the population of a previous study in this center³ . In concrete terms this means that the improvement in finger extension will be compared between the VIVOSORB® group, the control³ and the cellulose group³.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lore Hermans, CTA; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be
• Study Contact Backup: Name: Kristel Van de loock, CTA; Phone Number: +32 16 34 12 66; Email: orthopedie.research@uzleuven.be

Study Locations

• Belgium
  • Pellenberg, Belgium, 3212
    • UZ Leuven, Campus Pellenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vivosorb; Only arm in study	Device: Vivosorb; Resorbable implant device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	2 years post-surgery
EQ-5D-3L	Standardised instrument for use as a measure of health outcome	2 years post-surgery

Collaborators and Investigators

• Sponsor: prof. dr. Ilse Degreef
• Investigators: Principal Investigator: Ilse Degreef, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: S61390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No