NCT02543489Unknown不适用
A Prospective, Post-market, Multi-center Comparative Study of the Efficacy of Flex Intramedullary(IM) Rod in Terms of Range of Motion (ROM) Improvement.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Maximum postoperative flexion angle
研究概览
简要总结
The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 20 years or older.
- •Patient is candidate for primary Total Knee Arthroplasty (TKA).
- •Patient whose preoperative range of motion (ROM) is over 110 degree.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Revision cases
- •Patients that use bone wedges or allograft due to bone loss.
- •Patient has a Body Mass Index (BMI) >
- •Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient has failed unicondylar knee prosthesis.
- •Patient has a known sensitivity to device materials.
- •Patient who are inappropriate for participating in the study in the judgment of the investigator.
研究组 & 干预措施
Flex IM Rod
Other
干预措施: Flex IM rod (Device)
结局指标
主要结局
Maximum postoperative flexion angle
时间窗: 48 weeks after surgery
次要结局
- Quality of life as assessed by36-Item Short-Form Health Survey (SF-36)questionnaire(4 weeks , 24 weeks and 48 weeks after surgery)
- Japanese Knee Osteoarthritis Measure(JKOM)(4 weeks , 24 weeks and 48 weeks after surgery)
- Knee Society Scale (KSS)(4 weeks , 24 weeks and 48 weeks after surgery)
- Range of Motion (ROM)(4 weeks , 24 weeks and 48 weeks after surgery)
研究者
研究点 (6)
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