Post-contracture Release Radiation for Dupuytren's Disease

NCT04122313 | Recruiting

• 1 other identifier: ORTHOSURG-2018-26681
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Common Terminology Criteria for Adverse Events (CTCAE)

  2 years

Study Arms (1)

Patients with Dupuytren's Contracture Disease

Patients with Dupuytren's Disease following the current treatment pathway

Other: Evaluation of Dupuytren's Disease Treatment

Interventions

Evaluation of Dupuytren's Disease Treatment OTHER

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.

Patients with Dupuytren's Contracture Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnoses of Dupuytren's disease
• English-speaking

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leslie Chang

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Chang

CONTACT

612-273-6014; dupuytrensumn@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: May 31, 2019
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)