Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 16
- 主要终点
- Postoperative Range of Motion (ROM)
研究概览
简要总结
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
详细描述
This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, 21-80 years
- •Sex, Male and Females will be included
- •BMI less than or equal to 39
- •Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
- •Patient is willing and able to cooperate in follow-up therapy.
- •Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
- •Patient has stable and functional posterior cruciate and collateral ligaments.
- •Patient has potential to perform higher than average range of motion activities.
- •Operative side range of motion flexion greater than or equal to 120 degrees.
- •Severe knee pain and disability due to degenerative joint disease.
- •Patient or patient's legal representative has signed the Informed Consent form.
排除标准
- •Previous history of infection in the affected joint.
- •Previously failed knee endoprosthesis of any kind.
- •Charcot joint disease or other severe neurosensory deficits.
- •Previous patellectomy
- •Patient is skeletally immature.
- •Grossly insufficient femoral or tibial bone stock.
- •Patient is pregnant.
- •Varus or valgus deformity greater than 20 degrees.
- •Fixed flexion deformity greater than 15 degrees.
- •Previous high tibial osteotomy.
- •Previous femoral osteotomy.
- •Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
- •Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
结局指标
主要结局
Postoperative Range of Motion (ROM)
时间窗: 24 Months
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
次要结局
- Return to Function (RtF) Via Knee Scoiety Score (Modified)(24 Months)