ISRCTN60672307已完成未知
A randomised, multi-centre, non-blinded, prospective, parallel group trial of total ankle replacement (TAR) versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis, comparing clinical outcomes and cost-effectiveness
niversity College London (UCL) (UK)0 个研究点目标入组 303 人开始时间: 2014年5月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 303
研究概览
简要总结
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27601503 protocol (added 10/04/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36375147/ (added 15/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37022932/ (added 11/04/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38189868/ Cost-utility analysis (added 09/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 08/10/2014:
- •1. Diagnosis of end-stage ankle OA
- •2. Aged 50-85 years inclusive
- •3. The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
- •4. The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
- •5. The patient is willing and able to provide written informed consent
- •Previous inclusion criteria:
- •1. Diagnosis of end-stage ankle OA
- •2. Aged 50-85 years inclusive
- •3. The surgeon believes the patient is suitable for both TAR and arthrodesis
- •4. The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
- •5. The patient is willing and able to provide written informed consent
排除标准
- •Current exclusion criteria as of 08/10/2014:
- •1. Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
- •2. More than four lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
- •3. Unable to have MRI/CT scan (e.g., severe claustrophobia or contraindication for either scan)
- •4. History of local bone or joint infection
- •5. Any co-morbidity which, in the opinion of the investigator, is severe enough to interfere with the patient?s ability to complete the study assessments or presents an unacceptable risk to the patient?s safety
- •6. Participant in another clinical trial that would materially impact on their participation in this study
- •Previous exclusion criteria:
- •1. Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
- •2. More than four lower limb joints fused (including contralateral limb)
- •3. Significant deformity (>20 degrees at tibiotalar joint) on standing films
- •4. Ligamentous disruption (with clinical instability)
- •5. Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
- •6. Poorly controlled diabetes (HbA1c>9)
- •7. Poor vascular supply or soft tissue envelope
- •8. Above 15% AVN of the talus
- •9. History of local infection
- •10. Pregnancy (in women of childbearing potential)
- •11. Severe osteoporosis (T Score <-2.5) with recent fracture (<12 months)
- •12. Any co-morbidity (e.g., diabetes, heart condition, obesity, active cancer, psychiatric illness, hypermobility syndrome etc) which, in the opinion of the investigator, is severe enough to interfere with the patient?s ability to complete the study assessments or presents an unacceptable risk to the patient?s safety
- •13. The patient has participated in a clinical trial and has had an investigational medicinal product (IMP) administered within the last 3 months, or is currently participating in a clinical trial of a medical device
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