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

Nicolas Noiseux, MD, MS, FRCSC

Status: Enrolling

Conditions: Arthropathy of Knee

Treatments: Device: FM2 Knee Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT04924205

202002141

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Outpatient Physical Therapy

No Intervention group

Smart Orthotic Device (FM2 Knee Brace)

Experimental group

Treatment:

Device: FM2 Knee Brace