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Post-contracture Release Radiation for Dupuytren's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122313
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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
Dupuytren's Disease Dupuytren Contracture Dupuytren Disease of Palm and Finger Dupuytren Disease of 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 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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Southampton Dupuytren's Scoring System (SDSS) Questionnaire [ Time Frame: 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 :
  1. Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122313


Contacts
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Contact: Kathryn Dusenbery 612-273-6014 dupuytrensumn@umn.edu
Contact: Kathryn Dusenbery, MD 612-273-6014 dusen001@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kathryn Dusenbery, MD    612-273-6014    dupuytrensumn@umn.edu   
Contact       dusen001@umn.edu   
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04122313    
Other Study ID Numbers: ORTHOSURG-2018-26681
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dupuytren Contracture
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
 Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases