Prospective, Single-center, Non-randomized, Consecutive Series Study Comparing Functional Differences Between a Standard Posterior Stabilized TKR and a High-flexion Posterior Stabilized TKR
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
研究概览
简要总结
The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.
详细描述
The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient is indicated for total knee replacement with a posterior stabilized device.
- •Patient is between the ages of 50 and 80 years old
- •Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)
- •BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- •Patient is skeletally mature.
- •Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
- •Patient is willing and able to review and sign a study Informed Consent.
排除标准
- •Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)
- •BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- •Patient is skeletally mature
- •Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
- •Patient is willing and able to review and sign a study Informed Consent.
结局指标
主要结局
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.
时间窗: 2 years
Physician assess range of motion in knee joint
次要结局
- Hospital for Special Surgery (HSS) Knee Score(2 years)
- Patient Satisfaction(2 years)
- Knee Society Score (KSS)(2 years)
- Radiographic evaluation(2 years)
- Complications(2 years)
- Implant survivorship(2 years)