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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNicolas Noiseux, MD, MS, FRCSC

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior ipsilateral knee surgery

Prior manipulation under anesthesia of either knee

BMI > 40

Trial design

Design model

Parallel

Treatments tested in this trial

  • FM2 Knee Brace

    Device

    Participants in this group will use the FM2 Knee Brace for their post-TKA physical therapy.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Outpatient Physical TherapyNo intervention 0 interventions
Group B: Smart Orthotic Device (FM2 Knee Brace)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Range of Motion

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.

Time frame
pre-surgery
2

Range of Motion

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.

Time frame
6 weeks post-surgery
3

Range of Motion

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.

Time frame
3 months post-surgery
4

Range of Motion

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.

Time frame
1 year post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicolas Noiseux, MD, MS, FRCSC

Lead sponsor

University of Iowa

Sponsor institution