A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Implant alignment
研究概览
简要总结
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
详细描述
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-75 years at time of surgery.
- •Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
- •Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- •Patients who signed the study consent form prior to surgery.
排除标准
- •Pregnant women.
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- •Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- •Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
- •Muscle contracture around the knee joint
- •Individuals with active or suspected infection or sepsis.
- •Patients with contraindication to MRI
结局指标
主要结局
Implant alignment
时间窗: 6 weeks
Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs
次要结局
- Oxford Knee Score(1yr, 5yr, 10yr)