A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

Not Applicable

Recruiting

• Conditions: Arthropathy of Knee
• Interventions: Device: FM2 Knee Brace

• Registration Number: NCT04924205
• Lead Sponsor: Nicolas Noiseux, MD, MS, FRCSC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2021-09-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart Orthotic Device (FM2 Knee Brace)	FM2 Knee Brace	-

Primary Outcome Measures

Name	Time	Method
Range of Motion	1 year post-surgery	The study will collect measurements of knee flexion, extension, total arc of motion, and will also plan to record therapy compliance and complication rates. The two groups will be compared to study if the FM2 Knee Brace group is clinically non-inferior to the standard PT group with respect to knee range of motion.

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States