Evaluation of Intraoperative Soft-tissue Balance and Postoperative Functional Recovery After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Active and passive range of motion
研究概览
简要总结
The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system.
详细描述
This is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of OA who are eligible for primary total knee arthroplasty using the Persona total knee system.
The patients are equally divided in two groups; patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation. For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.
Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.
During each post-operative visit, the following metrics will be recorded:
- Active and passive range of motion
- Implant alignment
- Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the Persona total knee system
- •Patient is willing and able to provide written Informed Consent prior to study surgery
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form
排除标准
- •Patient does not have a primary indication of osteoarthritis
- •Patient does not have access to internet or mobile device or understand how to use phone/app
- •Patient is not eligible or will not receive the Persona total knee system
- •Patient has not provided written Informed Consent
结局指标
主要结局
Active and passive range of motion
时间窗: 1 year
Flexion and extension measurements of knee
Implant alignment
时间窗: 1 year post-operatively
Radiographic assessments
Knee Society Score (KSS)
时间窗: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.
Forgotten Joint Score (FJS)
时间窗: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 52 weeks post-operatively
Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability
次要结局
未报告次要终点
研究者
Alexander Sah, MD
Physician and Research Chair, Institute for Joint Restoration and Research
Washington Hospital Healthcare System