A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evidence of improved pain relief and function
研究概览
简要总结
The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of end-stage degenerative joint disease of the knee
- •must be deemed appropriate for total knee replacement surgery
排除标准
- •severe flexion deformity of the knee
- •greater than 20deg varus or valgus malalignment
- •osteomyelitis, septicemia, prior infection of the knee joint
- •presence of infections or highly communicable diseases
- •significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
- •metastatic disease
- •congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
- •previous total knee replacement in affected knee
- •arthrodesis of the affected knee
结局指标
主要结局
Evidence of improved pain relief and function
时间窗: Pre-op, 4 weeks, 4 months, 1 year, 2 years
次要结局
- Evidence of improved patellofemoral biomechanics(Pre-op, 4 months, 1 year)