Assessment of Radiotherapy in the management of Dupuytren’s Disease

Not Applicable

Recruiting

• Conditions: Dupuytren’s Disease; Inflammatory and Immune System - Connective tissue diseases

• Registration Number: ACTRN12618000951257
• Lead Sponsor: Genesis Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 568

Inclusion Criteria

Eligibility – All groups - (Prevention and Adjuvant)
- Patient consent
- No previous radiotherapy to the affected hand
- No history of radiation sensitivity diseases (eg Scleroderma, Ataxia Telangiectasia, Li
Fraumeni)
- Age>30
- Life expectancy >5 years
- Available and willing to participate in at least 5 years of follow-up
- Female patients capable of child-bearing are not pregnant

Eligibility – Prevention Arm
- Evidence of nodules and/or cords in the affected hand consistent with DD.
- History of progressive DD over previous 6 months.
- No previous SF, NA or CI in the affected hand.
- Absence of flexion contractures: PED must be less than, or equal to, 10 degrees in any joints of the affected hand.

Eligibility – Adjuvant Arm
- Local treatment with Needle Aponeurotomy (NA) of flexion
contracture(s) performed within 6-12 weeks prior to post-intervention baseline
measurements
- Lack of major acute complications due to surgical intervention and less than or equal to 20 degrees PED in all joints of affected rays and less than or equal to 10 degrees PED in remaining joints in the affected hand
- Able to commence radiotherapy treatment within 12 weeks of local treatment with Needle Aponeurotomy (NA).

Exclusion Criteria

Previous radiotherapy in the affected hand/s
Previous surgery in the affected hand/s
History of radiation sensitivity diseases (eg Scleroderma, Ataxia Telangiectasia, Li Fraumeni)
Pregnant patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint is Disease Progression, defined as: <br>- Prevention Group: Measurement of 20 degrees, or greater, PED in joint(s) of <br>an affected hand OR instigation of salvage SF or NA to the affected hand or <br>- Adjuvant Groups: Deterioration greater than 20 degrees PED in any joint(s) <br>of any of the affected digit(s) from post-intervention baseline in the presence <br>of a palpable cord OR instigation of salvage SF or NA to any of the affected <br>digit(s). <br>[ Baseline, 6, 12, 24, 36, 48 and 60, 84 and 108 months post treatment]