Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Knee injury and osteoarthritis outcome score (KOOS)
研究概览
简要总结
Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.
详细描述
Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.
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)
盲法说明
After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with degenerative knee arthritis with only one compartment affected
排除标准
- •Inflammatory Arthritis
- •Tricompartmental arthritis
- •Patients with fixed varus deformity greater than -10 degrees
- •Patients with fixed valgus deformity greater than -5 degrees
- •Patients with knee range of motion less than 90 degrees
- •Patients with more than 10 degrees of flexion contracture"
结局指标
主要结局
Knee injury and osteoarthritis outcome score (KOOS)
时间窗: 0-1 year
Knee injury and osteoarthritis outcome score (0-100)
Short Form Health Survey (SF-36)
时间窗: 0-1 year
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
次要结局
未报告次要终点
研究者
Murat Sarikas
orthopaedic surgeon
Bezmialem Vakif University