Recruiting

Smart Orthotic vs. Physical Therapy

Sponsor:

Nicolas Noiseux, MD, MS, FRCSC

Code:

NCT04924205

Conditions

Arthropathy of Knee

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

FM2 Knee Brace

Study Details

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.

Conditions

Arthropathy of Knee

Study ID

NCT04924205

Start date

Sep 1, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Outpatient Physical Therapy

experimental: Smart Orthotic Device (FM2 Knee Brace)

Interventions

FM2 Knee Brace

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

Primary outcome measure

  • Range of Motion [ Time Frame: pre-surgery ]
  • Range of Motion [ Time Frame: 6 weeks post-surgery ]
  • Range of Motion [ Time Frame: 3 months post-surgery ]
  • Range of Motion [ Time Frame: 1 year post-surgery ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Nicolas Noiseux, MD, MS, FRCSC

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nicolas Noiseux, MD, MS, FRCSC on 2026-03-25.