Post-contracture Release Radiation for Dupuytren's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger, Dupuytren Disease of Finger, Dupuytrens Contracture of Both Hands, Dupuytren's Disease of Palm of Right Hand, Dupuytren's Disease of Palm of Left Hand, Dupuytren Contracture of Right Palm, Dupuytren Contracture of Left Palm, Dupuytren's Contracture Left, Dupuytren's Contracture Right

Intervention / Treatment
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* Other: Evaluation of Dupuytren's Disease Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnoses of Dupuytren's disease English-speaking Exclusion Criteria: - Patients with Dupuytren's disease who are not currently seeking treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Dupuytren's Contracture Disease<br>Patients with Dupuytren's Disease following the current treatment pathway | Other: Evaluation of Dupuytren's Disease Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Southampton Dupuytren's Scoring System (SDSS) Questionnaire | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common Terminology Criteria for Adverse Events (CTCAE) | 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. | 2 years |