Bespoke vs Standard Instrumentation in TKR
Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.
This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.
研究概览
详细说明
Total knee replacement (TKR) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. However, this means that up to 25% of patients are not entirely satisfied with their TKR. The longevity and stability of a TKR is greatly dependent on the accuracy of the initial surgery. Deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'Patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. This will allow for individual bony cuts specific to the patients own anatomy.
'Patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. This could result in improved early range of movement and decreased pain following surgery. The total knee replacement used in this study will be the GMKSphere (Medacta International) TKR. It has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. It may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes.
Patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery.
This study will allow for comparison in knee function and patient outcomes between patients who have undergone their TKR with patient specific cutting blocks compared to conventional cutting blocks. The scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Lothian
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Edinburgh、Lothian、英国、EH16 4SA
- 招聘中
- Royal Infirmary of Edinburgh
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接触：
- 电话号码：0131 536 1000
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Exclusion Criteria:
- Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity > 5 degrees
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Patient Specific Cutting Blocks
For the bespoke individualised cutting blocks to be manufactured, the patients will undergo a preoperative CT scan under a set protocol.
The CT radiation dose will be considerably less than a conventional diagnostic CT scan.
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'MyKnee' Instrumentation
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有源比较器：Conventional Cutting Blocks
The patients in this arm will be operated on using conventional instruments.
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Standard Instrumentation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Limb alignment
大体时间：1 years
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Measured in degrees from Hip-Knee-Ankle radiographs from centre of femoral head to midpoint of the ankle
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1 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference between baseline pre-op and one year post-op change in gait measured using a bespoke clinic-appropriate motion analysis system.
大体时间：1 year
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Knee range of motion, strength and gait analysis assessments will be carried out on a bespoke clinic-appropriate motion analysis system.
This system consists of 8 Vicon B10 Bonita cameras (Vicon Systems, Oxford) which immediately surround a self-paced N-Mill treadmill (Motekforce Link, Amsterdam).
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1 year
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Difference in patient reported knee pain level as measured by Oxford Knee Score between baseline and one year and also between study groups.
大体时间：1 year
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Validated patient reported knee pain questionnaires as measured by Oxford Knee Score (out of 48 points) pre-operation and at one year post-operation.
Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
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1 year
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Difference in patient reported knee function between baseline and one year and also between study groups.
大体时间：1 year
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Validated patient reported knee function questionnaires as measured by EQ-5D pre-operation and at one year post-operation.
Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
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1 year
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Difference in patient reported quality of life questionnaires between baseline and one year and also between study groups.
大体时间：1 year
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Validated quality of life questionnaires as measured by SF-12 score pre-operation and at one year post-operation.
Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
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1 year
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Healthcare cost
大体时间：1 year
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Healthcare cost measured in pounds sterling (GBP).
Total cost of performing knee replacement using conventional cutting blocks compared to using bespoke cutting blocks and disposable instrumentation.
The measurable contributors to the costs of healthcare include operating time (minutes), number of instrument trays requiring sterilisation (number of trays), length of hospital stay (days), patient transfusion requirement (number of units of packed cells required), cost of bespoke disposable instrumentation (GBP).
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1 year
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合作者和调查者
赞助
调查人员
- 首席研究员：Leela C Biant, FRCSEd(Tr&Orth) MSres MFSTEd、University of Edinburgh
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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