Post-contracture Release Radiation for Dupuytren's Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dupuytren Contracture; Dupuytren Disease of Finger; Dupuytren's Disease; Dupuytren Disease of Palm and 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: Other: Evaluation of Dupuytren's Disease Treatment

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Leslie Chang; Phone Number: 612-273-6014; Email: dupuytrensumn@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Leslie Chang; Email: dupuytrensumn@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

English-speaking adults with a diagnosis of Dupuytren's disease whose have chosen to follow the current treatment pathway.

Description

Inclusion Criteria:

• Diagnoses of Dupuytren's disease
• English-speaking

Exclusion Criteria:

- Patients with Dupuytren's disease who are not currently seeking treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Leslie Chang, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Skin and Connective Tissue Diseases; Dupuytren Contracture
• Other Study ID Numbers: ORTHOSURG-2018-26681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No