Comparing rehabilitation methods after knee surgery using a smart brace and physical therapy
A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT04924205 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, similar studies have shown promise in using technology for rehabilitation, suggesting potential for success.
Eligibility criteria
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 this trial is running
Iowa City, Iowa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.