ACTRN12618000951257招募中未知
DEPART: Dupuytren’s disease Evaluation of Preventative or Adjuvant Radiation Therapy
Genesis Care0 个研究点目标入组 568 人开始时间: 2018年6月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 568
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 o limit(—)
- 性别
- All
入选标准
- •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
- •- 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).
排除标准
- •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
研究者
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