NCT04924205 A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
| NCT ID | NCT04924205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicolas Noiseux, MD, MS, FRCSC |
| Condition | Arthropathy of Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-09-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04924205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Arthropathy of Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04924205 currently recruiting?
Yes, NCT04924205 is actively recruiting participants. Contact the research team at lauren-keitel@uiowa.edu for enrollment information.
Where is the NCT04924205 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT04924205 clinical trial?
NCT04924205 is sponsored by Nicolas Noiseux, MD, MS, FRCSC. The trial plans to enroll 80 participants.