Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- NHS Lothian
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Limb alignment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
排除标准
- •Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity > 5 degrees
结局指标
主要结局
Limb alignment
时间窗: 1 years
Measured in degrees from Hip-Knee-Ankle radiographs from centre of femoral head to midpoint of the ankle
次要结局
- Difference in patient reported quality of life questionnaires between baseline and one year and also between study groups.(1 year)
- Difference between baseline pre-op and one year post-op change in gait measured using a bespoke clinic-appropriate motion analysis system.(1 year)
- Difference in patient reported knee pain level as measured by Oxford Knee Score between baseline and one year and also between study groups.(1 year)
- Difference in patient reported knee function between baseline and one year and also between study groups.(1 year)
- Healthcare cost(1 year)