Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

Patients with Dupuytren's Disease following the current treatment pathway

There are no study interventions. The study interaction will be asking the patients to complete an additional outcome questionnaire and allow a medical record review.

Evaluation of Dupuytren's Disease Treatment

Kathryn Dusenbery

Kathryn Dusenbery, MD

To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.

This is an observational, pilot study. Participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, PNA and CCH injection, followed by post-operative radiation. All enrolled participants will undergo radiation treatment as soon as possible following contracture release. Radiotherapy will consist of 5 daily treatments of 300 cGy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cGy, for a total of 3000 cGy in 10 total fractions. This dosing schedule is commonly used in the published literature. The data to be collected about participants, is their Southampton Dupuytren's score, history and clinical symptoms and photographs of their hand. This information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.

Post-contracture Release Radiation for Dupuytren's Disease

Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease

The primary study endpoint is the patient's self-reported function which will be assessed using the validated Southampton Dupuytren's Scoring System (SDSS) questionnaire. The SDSS is a 5 item questionnaire with item scores ranging from 0 (no problem) to 4 (severe problem). Total scores are a sum of the 5 item scores with a total score range of 0 to 20. High scores indicate greater impairment due to the disease.

The secondary endpoint will be the recurrence rate (which is defined as an increase in joint contracture on any treated joint of at least 20 degrees at one year post-treatment compared to six weeks post treatment) and skin toxicity, which will be assessed by CTCAE v5.0.

University of Minnesota

Vivosorb

Ilse Degreef, MD, PhD

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.

* 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.

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

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).

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.

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

Standardised instrument for use as a measure of health outcome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-contracture Release Radiation for Dupuytren's Disease	NCT04122313	Dupuytren's Dis... Dupuytren Contr... Dupuytren Disea... Dupuytren Disea... Dupuytrens Cont... Dupuytren's Dis... Dupuytren's Dis... Dupuytren Contr... Dupuytren Contr... Dupuytren's Con... Dupuytren's Con...	Evaluation of D...	18 Years -	University of Minnesota
Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device	NCT03741764	Dupuytren Contr... Dupuytren Disea...	Vivosorb	18 Years -	Universitaire Ziekenhuizen KU Leuven
Treatment of Dupuytren's Disease With Minimal Invasive Surgery and VIVOSORB® Resorbable Implant Device	NCT03741764	Dupuytren Contr... Dupuytren Disea...	Vivosorb	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for dupuytren disease of palm and finger