A Prospective, Randomized, Multi-centre Study of the Triathlon Cruciate Retaining Total Knee System Using ShapeMatch Cutting Guides
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
研究概览
简要总结
Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.
详细描述
This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an ethic commission approved study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- •Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Patient is a candidate for a primary total knee replacement.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) ≥
- •Patient age ≥
- •Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree.
- •Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
- •Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement.
- •Patient has any implanted device that would be incompatible with MRI procedures.
- •Patient has chronic heart failure (NYHA Stage ≥ 2)
- •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 requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
研究组 & 干预措施
Triathlon® CR/Kinematic Alignment
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
干预措施: Triathlon® CR/Kinematic Alignment (Device)
Triathlon® CR/Neutral Overall Limb Alignment
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.
干预措施: Triathlon® CR/Neutral Overall Limb Alignment (Device)
Triathlon® CR/Conventional Limb Alignment
Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.
干预措施: Triathlon® CR/Conventional Limb Alignment (Device)
结局指标
主要结局
Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.
时间窗: 6 months
To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.
次要结局
- Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test(1 year)
- Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).(1 year follow-up)
- Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.(1 year follow-up)
- Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).(1 year follow-up)
- Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.(1 year follow-up)
- Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).(1 year follow-up)