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NCT04924205 · ClinicalTrials.gov registry record · NA
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
A NA study of Arthropathy of Knee, sponsored by Nicolas Noiseux, MD, MS, FRCSC.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04924205 is a NA study of Arthropathy of Knee that is actively recruiting participants, run by Nicolas Noiseux, MD, MS, FRCSC. The registered enrollment target is 80 participants, roughly in line with the 80-participant average among 6 other Arthropathy of Knee trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT04924205, a NA study of Arthropathy of Knee, is actively recruiting participants, sponsored by Nicolas Noiseux, MD, MS, FRCSC.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE FM2 Knee Brace
Study Locations (1)
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04924205
The ClinicalTrials.gov registry entry for NCT04924205 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 80-participant average among 6 other Arthropathy of Knee trials with a reported enrollment target. The listed sponsor is Nicolas Noiseux, MD, MS, FRCSC, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arthropathy of Knee appearing as the primary indexed condition, and to 1 intervention - of which FM2 Knee Brace is the first listed.
NCT04924205 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT04924205 about?
NCT04924205 is a clinical study titled "A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy". 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 presc...
What is the current status of trial NCT04924205?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2021-09-01. Estimated completion is 2025-04.
What conditions does trial NCT04924205 study?
This clinical trial studies the following conditions: Arthropathy of Knee.
What interventions are being tested in trial NCT04924205?
The interventions under investigation include: FM2 Knee Brace (DEVICE).
Who is sponsoring clinical trial NCT04924205?
This trial is sponsored by Nicolas Noiseux, MD, MS, FRCSC, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04924205 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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