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

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ClinicalTrials.gov Identifier: NCT03741764
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
prof. dr. Ilse Degreef, Universitaire Ziekenhuizen Leuven

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.


Condition or disease Intervention/treatment Phase
Dupuytren Contracture Dupuytren Disease of Palm and Finger Device: Vivosorb Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Vivosorb
Only arm in study
Device: Vivosorb
Resorbable implant device




Primary Outcome Measures :
  1. Total Passive Extension Deficit (TPED) [ Time Frame: 2 years post-surgery ]
    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).


Secondary Outcome Measures :
  1. DASH score [ Time Frame: 2 years post-surgery ]
    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. VAS pain & satisfaction [ Time Frame: 2 years post-surgery ]
    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

  3. EQ-5D-3L [ Time Frame: 2 years post-surgery ]
    Standardised instrument for use as a measure of health outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741764


Contacts
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Contact: Lore Hermans, CTA +32 16 33 88 18 orthopedie.research@uzleuven.be
Contact: Kristel Van de loock, CTA +32 16 34 12 66 orthopedie.research@uzleuven.be

Sponsors and Collaborators
prof. dr. Ilse Degreef
Investigators
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Principal Investigator: Ilse Degreef, MD, PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: prof. dr. Ilse Degreef, Prof. Dr. Ilse Degreef, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03741764     History of Changes
Other Study ID Numbers: S61390
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases