Arthropathy of Knee
Conditions
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.
Interventions
DEVICEFM2 Knee Brace
Participants in this group will use the FM2 Knee Brace for their post-TKA physical therapy.
Sponsors
Nicolas Noiseux, MD, MS, FRCSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 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. |
Countries
United States
Contacts
CONTACTLauren Crowe, BS
CONTACTKyle Geiger, MD
Outcome results
None listed