NCT02535741已完成不适用
Clinical Outcome Study for the Triathlon CR Total Knee
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Mean Triathlon CR Active Range of Motion (ROM)
研究概览
简要总结
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.
详细描述
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- •Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
- •Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
- •Patients requiring a primary total knee replacement.
- •Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- •Patients with intact collateral ligaments.
排除标准
- •Patients with inflammatory arthritis.
- •Patients that are morbidly obese, body mass index (BMI) >
- •Patients with a history of total / unicompartmental reconstruction of the affected joint.
- •Patients that have had a high tibial osteotomy or femoral osteotomy.
- •Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- •Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration).
- •Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- •Patients with a knee fusion to the affected joint.
- •Patients with an active or suspected latent infection in or about the knee joint.
- •Patients with a history of total joint replacement on the opposite knee within less than 1 year.
- •Patients requiring bilateral total knee replacement.
研究组 & 干预措施
Triathlon CR Total Knee System
Other
Primary total knee replacement
干预措施: Triathlon CR Total Knee System (Device)
结局指标
主要结局
Mean Triathlon CR Active Range of Motion (ROM)
时间窗: 2 years follow-up
Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.
次要结局
- Investigation of Patient Outcome With Radiographic Analysis(Pre-operative, 3 months, 1, 2 and 5 years follow-up)
- Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire(Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up)
- Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire(Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up)
- Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up)
研究者
研究点 (12)
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