Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04924205
Status:
RECRUITING
Last Update Posted:
2024-07-22
First Post:
2021-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
Sponsor:
Nicolas Noiseux, MD, MS, FRCSC
Organization:
Study Overview
Official Title:
A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: