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Clinical Trials/NCT04924205
NCT04924205
Recruiting
N/A

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

Nicolas Noiseux, MD, MS, FRCSC1 site in 1 country80 target enrollmentSeptember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arthropathy of Knee
Sponsor
Nicolas Noiseux, MD, MS, FRCSC
Enrollment
80
Locations
1
Primary Endpoint
Range of Motion
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
April 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nicolas Noiseux, MD, MS, FRCSC
Responsible Party
Sponsor Investigator
Principal Investigator

Nicolas Noiseux, MD, MS, FRCSC

Investigator

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Range of Motion

Time Frame: 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.

Study Sites (1)

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