Comparison of Multiradius and Singleradius Prosthesis Design in Total Knee Arthroplasty Using With Association Sagittal Patellar Offset and Anterior Knee Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- anterior patellar offset ratio
研究概览
简要总结
The Investigators would like to compare multiradius and single-radius total knee arthroplasty using with association between sagittal patellar offset and anterior knee pain in subjects having undergone bilateral total knee replacement.
详细描述
A prospective, interventional study. A total of to 494 subjects requiring bilateral multiradius( n=247) and singlerasius(n=247) knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain. In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset". Sagittal patellar offset is accepted by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of end-stage primary gonarthrosis
排除标准
- •History of malignancy,
- •Severe extraarticular deformity,
- •Posttraumatic and septic arthritis sequel
结局指标
主要结局
anterior patellar offset ratio
时间窗: From the date of randimization until the final follow up of last patient, assessed up to 15 months
The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset".Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
次要结局
未报告次要终点
研究者
Orkhan Aliyev
Resident Doctor, Department of Orthopaedics and Traumatology, Principal Investigator
Bezmialem Vakif University