Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients with Anteromedial Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw, IN) mobile bearing unicompartmental knee arthroplasty.
Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis from the investigating gait lab.
The investigators hypothesize that post-operative UKA patients will display higher clinical scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The investigators further hypothesize that the biomechanics data will assist in the understanding of the outcome score differential both pre- and post-operatively in both groups, as well as between-groups.
Total follow up period will be two years.
详细描述
Title:
Unicondylar knee arthroplasty versus total knee arthroplasty in patients with anteromedial osteoarthritis of the knee.
Rationale:
Unicompartmental knee arthroplasty (UKA) offers several possible advantages over total knee arthroplasty (TKA). One important possible advantage is overall higher patient satisfaction with UKA. Patients have superior post-operative range of motion and a more "natural-feeling" knee. Previously, patients with patellofemoral joint osteoarthritis (PFJOA) were excluded from UKA. However, recent studies suggest that excellent results can be achieved with UKA despite pre-existing moderate PFJOA. This may broaden pre-defined inclusion criteria for UKA. To date, no biomechanical studies directly comparing UKA and TKA have been performed. Biomechanical data could help explain outcome differences. This study aims to compare both clinical and biomechanical outcomes in patients receiving UKA versus TKA for anteromedial OA in the presence of no to moderate PFJOA.
Hypothesis:
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anteromedial compartment osteoarthritis (OA) with intact anterior cruciate ligament (ACL) by clinical testing and alignment on radiographs;
- •normal or mild to moderate patellofemoral joint OA
- •angular deformity <15 degrees passively correctible to neutral;
- •flexion contracture<5 degrees;
- •age 40-80 years
排除标准
- •severe PFJOA;
- •history of previous surgery on the affected knee (excluding simple meniscectomy);
- •inflammatory arthropathy;
- •previous contralateral knee replacement surgery or major ligament reconstruction surgery
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 2 years
Oxford Knee Score (OKS)
时间窗: 2 years
次要结局
- Gait analysis score(1 year)
研究者
Kelly Johnston
Chief, Division of Joint Reconstruction - University of Calgary
Alberta Hip and Knee Clinic