University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Location status: Recruiting
Recruiting
NCT Number: NCT04924205
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
FM2 Knee Brace
DeviceParticipants in this group will use the FM2 Knee Brace for their post-TKA physical therapy.
Primary outcomes
-
Range of Motion
Time frame: pre-surgery
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.
-
Range of Motion
Time frame: 6 weeks post-surgery
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.
-
Range of Motion
Time frame: 3 months post-surgery
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.
-
Range of Motion
Time frame: 1 year post-surgery
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nicolas Noiseux, MD, MS, FRCSC
Other
Registry information
Official study title
A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
Important dates
- Study start
- 2021
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jun 11, 2021
- Registry last updated
- Mar 25, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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