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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924205
• Other study ID #: 202002141
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: University of Iowa
• Contact: Lauren Crowe, BS
• Phone: 319-467-7128
• Email: lauren-keitel[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Nicolas Noiseux, MD FRCSC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-surgery
Primary	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.	6 weeks post-surgery
Primary	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.	3 months post-surgery
Primary	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.	1 year post-surgery