Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient-reported outcomes (disease-specific and generic QoL instruments)
研究概览
简要总结
This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.
详细描述
Isolated patellofemoral osteoarthritis can be a disabling condition of the knee necessitating knee arthroplasty. It is debated whether total knee replacement or isolated patellofemoral replacement is the better treatment option. This randomized trial attempts to give a qualified answer to the debate by comparing clinical outcome (range of movement, stability, effusion, patellofemoral tracking, tenderness, stair climbing), patient self assessment scores (EQ-5D, Oxford Knee Score, KOOS, SF-36, AKS), complications (infections, revisions), longevity (survival analysis) and cost (direct and indirect) for the two implant types.
The Avon patellofemoral implant has been chosen, as this is the patellofemoral implant with the best documentation. The PFC Sigma CR total knee implant has been chosen as it a current standard implant and market leader.
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)
盲法说明
Patients are blinded to treatment allocation for the first year; they are un-blinded at the one-year follow-up. Hospital staff, excluding the surgical team, are likewise blinded. Discharge letters are intended to exclude implant information to ensure general practitioner blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated PF-OA
排除标准
- •Medial or lateral OA
研究组 & 干预措施
Avon patellofemoral replacement
Knee arthroplasty with insertion of patellofemoral joint replacement.
干预措施: Knee arthroplasty (Device)
PFC Sigma CR total knee replacement
Knee arthroplasty with total (tricompartmental) knee replacement.
干预措施: Knee arthroplasty (Device)
结局指标
主要结局
Patient-reported outcomes (disease-specific and generic QoL instruments)
时间窗: 10 years
The physical functioning score of the Short Form (36) Health Survey is the primary outcome measure of the study. Disease-specific patient-reported outcomes (Oxford Knee Score, KOOS and Kujala) and a second generic quality of life measure (EQ5D).
次要结局
- Implant survival, clinician assessment and cost.(10 years)