SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- WOMAC Osteoarthritis Index Function
研究概览
简要总结
This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.
详细描述
RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.
Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for primary TKA
- •non-inflammatory arthritis
- •intact Posterior Cruciate Ligament at the time of surgery
排除标准
- •required bone grafting of either the femur or tibia
- •varus or valgus deformity of > 15 degrees
- •previous high tibial osteotomy
- •unable to understand or comply with the study requirements
- •unable to provide signed informed consent
结局指标
主要结局
WOMAC Osteoarthritis Index Function
时间窗: 10 years
disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores
Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain
时间窗: 10 years postoperative
disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores
次要结局
- RAND -36 Health Survey(10 years postoperative)
- Number of Complications(within 10 years of surgery)
- Revision Rate(within 10 years of surgery)
- Knee Range of Motion(knee ROM at 2 years postoperative)