NCT01367938已完成不适用
OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
Spokane Joint Replacement Center1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2009年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Clinical outcomes
研究概览
简要总结
A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 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 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).
- •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 that computer-assisted surgical navigation (CAOS) techniques will be used.
- •Patients that minimally invasive surgical technique will be used.
- •Patients that are prisoners.
结局指标
主要结局
Clinical outcomes
时间窗: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Clinical outcomes to include overall success, revision rate, adverse events, clinical score (Knee Society Score), range of motion, radiographic findings.
次要结局
未报告次要终点
研究者
David F. Scott, MD
PI
Spokane Joint Replacement Center
研究点 (1)
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