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临床试验/NCT04924205
NCT04924205招募中不适用

A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

Nicolas Noiseux, MD, MS, FRCSC2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Range of Motion

研究概览

简要总结

This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-100
  • Indicated for primary total knee arthroplasty
  • Possess a smartphone with capabilities to use the FocusMotion app and FM2 Knee Brace
  • Home discharge post-operatively

排除标准

  • Prior ipsilateral knee surgery
  • Prior manipulation under anesthesia of either knee
  • BMI > 40

结局指标

主要结局

Range of Motion

时间窗: 1 year post-surgery

The study will collect measurements of knee flexion, extension, total arc of motion, and will also plan to record therapy compliance and complication rates. The two groups will be compared to study if the FM2 Knee Brace group is clinically non-inferior to the standard PT group with respect to knee range of motion.

次要结局

未报告次要终点

研究者

发起方
Nicolas Noiseux, MD, MS, FRCSC
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicolas Noiseux, MD, MS, FRCSC

Investigator

University of Iowa

研究点 (2)

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