Post-contracture Release Radiation for Dupuytren's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Dupuytren's Contracture Disease Patients with Dupuytren's Disease following the current treatment pathway |
Other: Evaluation of Dupuytren's Disease Treatment
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.
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Outcome Measures
Primary Outcome Measures
- Southampton Dupuytren's Scoring System (SDSS) Questionnaire [2 years]
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.
Secondary Outcome Measures
- Common Terminology Criteria for Adverse Events (CTCAE) [2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnoses of Dupuytren's disease
-
English-speaking
Exclusion Criteria:
- Patients with Dupuytren's disease who are not currently seeking treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORTHOSURG-2018-26681