Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
研究概览
简要总结
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
详细描述
Hypothesis
TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
- •Subject must be diagnosed with one or more of the following conditions
- •osteoarthritis
- •rheumatoid or other inflammatory arthritis
- •post-traumatic arthritis
- •Subject is likely to be available for all study visits
- •Subject is able and willing to sign the informed consent and follow study procedures
排除标准
- •Prior Total Knee Arthroplasty
- •Avascular Necrosis
- •Any knee surgery other than meniscectomy (can be arthroscopic or open)
- •Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- •Ipsilateral foot/ankle and hip arthritis
- •Range of motion less than 90°, flexion contracture greater than 20°
- •Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- •Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
结局指标
主要结局
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
时间窗: Intra-operative with trial implants in place and after completing all surgical corrections.
Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.
次要结局
- Forgotten Joint Score (FJS)(6 weeks, 6 months, 1 year, 2 years)
- Knee Society Knee Scoring System(pre-operative, 6 weeks, 6 months, 1 year, 2 years)
- Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).(Pre-operative, 6 weeks, 6 months, 1 year and 2 years)