A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Contact Information
Primary
Lauren Crowe, BS
lauren-keitel@uiowa.edu
319-467-7128
Backup
Kyle Geiger, MD
kyle-geiger@uiowa.edu
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-04
Participants
Target number of participants: 80
Treatments
No_intervention: Outpatient Physical Therapy
Experimental: Smart Orthotic Device (FM2 Knee Brace)
Related Therapeutic Areas
Sponsors
Leads: Nicolas Noiseux, MD, MS, FRCSC

This content was sourced from clinicaltrials.gov