Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Operative record
研究概览
简要总结
The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.
详细描述
The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the Oxford Knee
- •symptomatic unicompartmental knee arthritis major surgery
- •failed non operative treatment modalities
- •willing and able to give informed consent
- •skeletal maturity
排除标准
- •for the Oxford Knee
- •medical conditions that preclude general or spinal anesthetic
- •ipsilateral knee avascular necrosis
- •severe osteoporosis or osteopenia
- •neuromuscular impairment
- •ipsilateral knee infection
- •Patient day surgery criteria
- •medically stable: an ASA category of 1 or 2
- •close proximity to the hospital surgery performed for at least 36 hours
- •good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op.
- •hemovac to be removed prior to discharge
- •access to VON or other home care hospital approved services
- •pain buster for pain control for 24 to 36 hours
研究组 & 干预措施
Computer Navigational Unit Assistance
Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit.
干预措施: Oxford Unicompartmental Knee (Device)
Non- Computer Navigational Unit Assisted
Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit).
干预措施: Oxford Unicompartmental Knee (Device)
结局指标
主要结局
Operative record
时间窗: Immediately Post-Op
American Knee Society Score (AKSS)
时间窗: 1 year
Visual Analogue for pain, activity, and patient satisfaction (VAS)
时间窗: 1 year
次要结局
- Radiographic Output(1 year)
- Gait Belt Analysis(1 year)
- Oxford Knee 12(1 year)
- SF 12(1 year)
- Western Ontario MacMaster(WOMAC)(1 year)