None listed
Conditions
Brief summary
This trial will assess patients with Dupuytren’s Disease in two settings: those who have early stages of the disease, and those who have progressive flexion contractures. It is the first trial of its kind and aims to assess safety and efficacy in the use of radiotherapy in both settings. We hypothesise that radiotherapy reduces the incidence of disease progression in people with Dupuytren’s Disease managed in the early stages with a policy of observation, or in the later stages following local treatment in the form of NA.
Interventions
Currently, treatment for early phase Dupuytren’s Disease is observation and in the later phase of the condition, treatment is surgery. As a randomised controlled trial, treatment will be allocated as follows:
- Preventative Therapy: Observation or Radiation Therapy
- Adjuvant Therapy: Needle Aponeurotomy (NA) followed by observation or NA followed by Radiation Therapy. Note: Adjuvant therapy is determined at the discretion of the Clinician and patient decision.
Radiotherapy will be targeted to
Currently, treatment for early phase Dupuytren’s Disease is observation and in the later phase of the condition, treatment is surgery. As a randomised controlled trial, treatment will be allocated as follows: - Preventative Therapy: Observation or Radiation Therapy - Adjuvant Therapy: Needle Aponeurotomy (NA) followed by observation or NA followed by Radiation Therapy. Note: Adjuvant therapy is determined at the discretion of the Clinician and patient decision. Radiotherapy will be targeted to the affected hand and over a split course. More specifically, 5 fractions of Radiation Therapy in one week, then 5 again after a 4-12 week break. This will be a total of 30Gy in 10 Fractions.
Sponsors
Genesis Care
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed