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 type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | July 2028 |
| Study ends | December 2028 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT04924205 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
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States Recruiting
Study contacts
- Study coordinator: Lauren Crowe, BS
- Email: lauren-keitel@uiowa.edu
- Phone: 319-467-7128
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mako-MORE Registry: Real-world Outcomes After Knee and Hip Arthroplasty
This registry collects real-world data from adults having hip or knee joint replacement with or without the Mako robotic system to see how they do over up to five years.
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Total knee replacement with a polyethylene tibial component to see how long it lasts and how patients do
This study tests the 5-year survival and clinical outcomes of a total knee replacement using an all-polyethylene tibial component in people aged 50–85 with knee osteoarthritis or related conditions.
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Breathing exercises before joint surgery
This study is testing if breathing exercises before joint surgery can help patients breathe better after their operation and avoid complications.
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Comparing total knee replacement to robotic-assisted partial knee replacement
This study is testing whether robotic-assisted partial knee replacement helps people with severe knee arthritis recover better and feel more functional than traditional total knee replacement.
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Comparing fast track and standard care for total knee replacement
This study is testing if a quicker recovery plan for knee replacement surgery helps patients feel better and recover faster compared to the usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.