Post-contracture Release Radiation for Dupuytren's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Evaluation of Dupuytren's Disease Treatment.
- Who it may be relevant to
- Registry conditions: Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger, Dupuytren Disease of Finger. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
Overview
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
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.
Interventions
- 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.
Primary outcome measures
- Southampton Dupuytren's Scoring System (SDSS) Questionnaire [Time frame: 2 years]
Secondary outcome measures (1)
- Common Terminology Criteria for Adverse Events (CTCAE) [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Diagnoses of Dupuytren's disease
- English-speaking
Exclusion criteria
\- Patients with Dupuytren's disease who are not currently seeking treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT04122313 · ORTHOSURG-2018-26681