NCT03391323已完成不适用
Medacta GMK Sphere® Medial-Pivot, Cruciate Substituting vs. Medacta GMK PS Posterior Stabilized Kne vs. OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
David F. Scott, MD2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Forgotten Joint Score (FJS)
研究概览
简要总结
The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Patients willing to sign the Informed Consent.
- •Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
- •Male and non-pregnant female patients ages 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 or unicompartmental reconstruction of the affected joint.
- •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), excluding inhalers.
- •Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- •Patients with knee fusion to the affected joint.
- •Patients with an active or suspected latent infection in or about the knee joint.
- •Patients whose surgery will utilize computer-assisted surgical navigation (CAOS) techniques.
- •Patients whose surgery will utilize minimally invasive surgical techniques.
- •Patients that are prisoners.
结局指标
主要结局
Forgotten Joint Score (FJS)
时间窗: Change from baseline at 2 years and 5 years post-operative
The average Forgotten Joint Score (FJS) of those patients receiving the Medacta GMK Sphere® knee prosthesis will be compared with the average FJS of those receiving the Medacta GMK PS knee prosthesis. The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.
次要结局
- Radiographic Analysis(Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative)
- Total Knee Society Score (KSS)(Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative)
- Lower Extremity Activity Scale (LEAS)(Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative)
研究者
David F. Scott, MD
Principal Investigator
Spokane Joint Replacement Center
研究点 (2)
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