NCT03387839已完成不适用
Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
David F. Scott, MD1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1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
- 100
- 试验地点
- 1
- 主要终点
- Measurement of antero-posterior stability of the knee with stress x-rays.
研究概览
简要总结
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 informed consent.
- •Patients able to comply with study requirements including stress x-rays and self-evaluations.
- •Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
- •Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
- •Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- •Patients with intact collateral ligaments.
- •Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.
排除标准
- •Patients with inflammatory arthritis.
- •Patients that are morbidly obese, body mass index (BMI) >
- •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), 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 that are prisoners.
结局指标
主要结局
Measurement of antero-posterior stability of the knee with stress x-rays.
时间窗: 1 year post-operative
Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion. Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.
次要结局
- Knee Society Score (KSS)(1 year post-operative)
- Lower Extremity Activity Scale (LEAS)(1 year post-operative)
- Forgotten Joint Score (FJS)(1 year post-operative)
研究者
David F. Scott, MD
Principal Investigator
Spokane Joint Replacement Center
研究点 (1)
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