Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- OKS
研究概览
简要总结
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
详细描述
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs. The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies. MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures. An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80 years
- •Indication for medial UKP
- •Intact anterior cruciate ligament
- •Good bone quality based on imaging
- •ASA score ≤ 3
排除标准
- •Inflammatory joint diseases
- •Collateral ligament instability
- •Simultaneous bilateral procedure
- •BMI > 35
- •History of fracture or osteotomy in the knee joint
- •Neuromuscular diseases
- •Oncological indications
结局指标
主要结局
OKS
时间窗: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
Oxford Knee Score
次要结局
- AMI(Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.)
- Surgery time(Peroperatively)
- Complications(Within 2 years postoperatively)
- Revision or reoperation(Within 2 years postoperatively)
- c-FCA(6 weeks and 4 months postoperatively)
- EQ-5D-5L(Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.)
- NRS(Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.])
- KOOS-PS(Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.)
- c-TCA(6 weeks and 4 months postoperatively)
- s-FCA(6 weeks and 4 months postoperatively)
- RLL(6 weeks and 4 months postoperatively)
研究者
Lenka Stroobant
MD-PhD
Jan Yperman Hospital