Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT04924205

A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

Led by Nicolas Noiseux, MD, MS, FRCSC · Updated on 2026-03-25

80

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

L

Lauren Crowe, BS

CONTACT

K

Kyle Geiger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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