The Effects of Postoperative Positioning in Knee Flexion Versus Usual Care After Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Knee Passive Total Arc of Motion
研究概览
简要总结
Many total knee replacements are performed each year, but there is no clear recommendation regarding knee positioning following this surgery. While the surgical knee is usually positioned in a straight position immediately after surgery, there may be benefits of positioning it in a partially bent position. A trial will compare the outcomes of two groups of patients: a) those whose knees are positioned in a partially bent position for a few hours after surgery and b) those who receive usual care where the knee is most likely positioned in a straight position. The investigators are looking to see whether knee motion and pain differ for patients in the two groups.
详细描述
This parallel two-arm randomized controlled trial will compare outcomes for knee flexion versus usual care in the immediate postoperative period after total knee arthroplasty. Patients who are scheduled for elective primary unilateral total knee arthroplasty will be recruited from an academic health system, screened for inclusion/exclusion criteria, and enrolled. The experimental group will have their surgical knee positioned in approximately 60° of flexion for 2-4 hours after surgery. The control group will receive usual care, where the knee will generally be positioned in extension. Other than the study intervention, both groups will receive standard perioperative, intraoperative, and postoperative care as determined by their treating clinical team. The co-primary endpoints are 6-week knee passive total arc of motion and 7-day maximum pain intensity. Secondary outcomes will be assessed throughout the 12 months after surgery and will include knee motion and pain intensity at other time points; oral opioid consumption; patient-reported questionnaires of knee health, quality of life, and satisfaction; healthcare utilization; and complications. Adverse events will also be monitored for the 12 months after surgery. Outcomes will be assessed via phone or electronic surveys; routine care visits at 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery; and chart review.
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 (Care Provider)
盲法说明
Participant arm assignment will be concealed from the surgeon who will leave the operating room before the knee is positioned. The surgeon will also be the assessor of the primary 6-week knee total arc of motion endpoint. The patient and investigators assessing other endpoints will not be masked to the arm.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Males and females; Age >18 years
- •Scheduled for elective primary unilateral total knee arthroplasty
- •The planned arthroplasty is secondary to physician-confirmed diagnosis of knee osteoarthritis
- •English- or Spanish-speaking
排除标准
- •Patients with a history of chronic opioid use or chronic pain disorders
- •Patients with a history of bleeding disorders/coagulopathy
- •Patients receiving a total knee replacement secondary to trauma, avascular necrosis, tumor, or Charcot arthropathy
- •Patients scheduled to undergo multiple procedures simultaneously
- •Patients with cognitive impairment or inability to consent independently
研究组 & 干预措施
Knee Flexion
Participants in this arm will receive the knee flexion intervention.
干预措施: Knee Flexion (Other)
Usual Care
Participants in this arm will receive usual care. No specific attention will be placed to knee positioning in the immediate period after surgery. However, the current usual practice in the health system is that the knee is positioned in extension.
干预措施: Standard Care (Procedure)
结局指标
主要结局
Knee Passive Total Arc of Motion
时间窗: At 6 weeks after surgery
Passive total arc of motion will be evaluated through goniometric assessment of maximal passive knee flexion and passive knee extension. Both measures will be recorded, but a single endpoint will be derived by subtracting available extension from available flexion.
Maximum Pain Intensity
时间窗: At 7 days after surgery
Pain intensity will be evaluated via the patient-reported Numeric Rating Scale (NRS) for pain. The rating is from 0 to 10, with a higher score indicating worse pain. The worst (i.e., maximum) pain intensity will be used.
次要结局
- Knee Passive Total Arc of Motion(At 2.5 weeks, 3 months, 6 months, and 12 months after surgery)
- Maximum Pain Intensity(At 0 days, 1 day, 2 days, 3 days, 10 days, 14 days, 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery)
- Total Opioid Consumption(Postoperative days 0 through 14)
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(At 6 weeks, 3 months, 6 months, and 12 months after surgery)
- Veterans RAND 12-item Health Survey(At 6 weeks, 3 months, 6 months, and 12 months after surgery)
- Goodman Satisfaction Score(12 months after surgery)
- Length of Hospital Stay(Through hospital discharge, average of 1 day, up to 30 days after surgery)
- Percentage of Participants with an Emergency Department Visit(Within 7 days, 30 days, and 90 days after surgery)
- Percentage of Participants with a Hospital Readmission(Within 30 days and 90 days after surgery)
- Percentage of Participants with Deep Vein Thrombosis(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Pulmonary Embolism(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Venous Thromboembolism(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Coronary Event(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Stroke(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Blood Transfusion(Within 30 days after surgery)
- Percentage of Participants with a Wound Dehiscence(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Mechanical Complication(Within 30 days and 90 days after surgery)
- Percentage of Participants with a Manipulation under Anesthesia(Within 12 months after surgery)
- Percentage of Participants with a Knee Revision Surgery(Within 12 months after surgery)
研究者
Brett Hayden
Assistant Professor
Icahn School of Medicine at Mount Sinai