Randomized Controlled Trial of Patients Undergoing a Total Knee Arthroplasty With and Without the Use of Intraoperative Sensing Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this study is to determine if there is a difference in clinical outcomes after total knee replacement (TKR) performed with traditional ligament balancing compared to use of intraoperative sensing technology (IOS) to balance ligaments. IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants. A total of 150 subjects will participate in this study at Hospital for Special Surgery.
The hypotheses are that the use of IOS technology will be associated with:
- Better soft tissue balance during TKR than by manual balancing alone.
- Higher patient reported clinical outcome measures (PROMs) following surgery.
详细描述
Participation in this study will involve a knee replacement performed with IOS. Patients will be randomized into one of two groups:The study group will have soft tissue balance performed with the use of IOS. Control group patients will have soft tissue balance performed manually, with final soft tissue balance values measured using IOS, while the surgeon will remain blinded to those values. Intra-operative compartment loads will be measured in 10, 45, and 90 degrees of flexion.
Additionally, long leg limb alignment, passive range of motion, use of opioids, daily activity, and PROMS will be evaluated post-operatively to determine which group has better outcomes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the indications for use for primary TKR using IOS
- •Subject must be diagnosed with osteoarthritis
- •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
- •Revision total knee arthroplasty
- •Patient is receiving treatment for any of the following conditions:
- •Avascular Necrosis
- •Inflammatory arthritis
- •Post-traumatic arthritis
- •Any knee surgery other than meniscectomy (can be arthroscopic or open)
- •Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- •Ipsilateral foot/ankle and hip arthritis
- •Range of motion less than 90°
- •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.
- •Patient out-of-state with medication prescription not registered in iStop database
- •Patients with severe contralateral osteoarthritis requiring subsequent knee replacement or with a flexion contracture greater than 10 degrees.
结局指标
主要结局
Knee Society Score
时间窗: 4 months
The primary outcome will be the difference in Knee Society Score (KSS) between baseline and 4 months post-operatively. The Knee Society Score is out of 100 points, with a higher score meaning a patient had a better outcome.
次要结局
- Intra-operative Compartment Loads(Intra-operative)
- Long Leg Limb Alignment(6 weeks)
- Passive Range of Motion(4 months)
- Opioid Use(6 weeks)
- Function and Activity(6 weeks)
- Pain Level(6 weeks)