Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- KOOS knee score
研究概览
简要总结
There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.
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)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
排除标准
- •systemic inflammatory arthropathy
- •tibiofemoral joint degeneration IKDC grade C or worse
- •severe degeneration of also the trochlea margins (inlay PFA not adequate)
- •patellectomy
- •previous implantation of tibiofemoral metal implants
- •extension loss >5 degree
- •knee flexion of less than 100°
- •planned concomitant tibiofemoral procedures (eg. coronal plane osteotomies, tibiofemoral cartilage procedures, tibiofemoral ligament procedures)
结局指标
主要结局
KOOS knee score
时间窗: 1 year
次要结局
- Kujala Score(1 year)
- Marx Activity Scale(1 year)
- HSS patella Score(1 year)
研究者
Michael Liebensteiner
Principal Investigator and Coordinating Investigator
Medical University Innsbruck