Comparing a Smart Knee Brace to Physical Therapy After Knee Replacement

This study is comparing two ways to recover after a total knee replacement (TKA). One group will use a smart knee brace called the FM2 Knee Brace, and the other group will have standard outpatient physical therapy. You might be able to join if you are between 18 and 100 years old, are having your first total knee replacement, have a smartphone that can use the brace's app, and will go home after surgery. The study will look at how well you can move your knee (range of motion) before surgery, and then again at 6 weeks and 3 months after surgery. The current recruitment status is unclear.

Study design
This is a randomized study comparing two rehabilitation methods after total knee replacement. About 80 participants will be involved.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your knee's range of motion will be measured up to 3 months after surgery.

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NCT04924205

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

Recruiting
NAAges 18+Interventional
Nicolas Noiseux, MD, MS, FRCSC
~80 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:FM2 Knee Brace

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Range of Motion
Measured over pre-surgery
+3 more outcomes measured
Arthropathy of Knee
1 sites across 1 states
Iowa1

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Eligibility criteria

Inclusion

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

Prior ipsilateral knee surgery
Prior manipulation under anesthesia of either knee
BMI \> 40
  • Range of Motionpre-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.

  • Range of Motion6 weeks 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.

  • Range of Motion3 months 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.

  • Range of Motion1 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.