Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Comparing rehabilitation methods after knee surgery using a smart brace and physical therapy

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

Run by University of Iowa · NCT04924205 · Data updated 2026-11-12

This study is testing whether using a smart knee brace after knee surgery can help people recover just as well as traditional physical therapy.

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment80 (estimated)
SponsorUniversity of Iowa
Academic / other
Locations1 site (Iowa City, Iowa)
StatusRecruiting
StartedSeptember 1, 2021
Main results expectedJuly 2028
Study endsDecember 2028
Registry record updatedMarch 25, 2026
Trial IDNCT04924205 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-100 who are scheduled for primary total knee arthroplasty and have access to a smartphone for app usage.

Probably not a fit

Patients with prior knee surgeries, a BMI over 40, or those unable to use the required smartphone app may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, randomized, noninferiority comparison of rehabilitation methods following total knee arthroplasty (TKA). It involves adult patients over 18 years old who are scheduled for unilateral primary TKA. Participants will be randomized into two groups: one receiving traditional outpatient physical therapy and the other using a validated smart knee brace for rehabilitation. The study aims to evaluate the effectiveness of the smart brace against standard physical therapy in improving recovery outcomes post-surgery.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and effective rehabilitation option for patients recovering from knee surgery.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in using technology for rehabilitation, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.