Post-contracture Release Radiation for Dupuytren's Disease

Dupuytren Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122313
• Other study ID #: ORTHOSURG-2018-26681
• Status: Recruiting
• Start date: May 31, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: Kathryn Dusenbery
• Phone: 612-273-6014
• Email: dupuytrensumn[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnoses of Dupuytren's disease

• English-speaking

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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