Clinical trial NCT03741764: Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device
Official title: Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dupuytren Contracture
Dupuytren Disease of Palm and Finger
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Total Passive Extension Deficit (TPED)
timeFrame: 2 years post-surgery
Secondary outcomes:
measure: DASH score
timeFrame: 2 years post-surgery
measure: VAS pain & satisfaction
timeFrame: 2 years post-surgery
measure: EQ-5D-3L
timeFrame: 2 years post-surgery
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: UZ Leuven, campus Pellenberg
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ilse Degreef, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: