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Smart Orthotic vs Physical Therapy for Knee Arthropathy

N/A
Recruiting
Research Sponsored by Scott Muffly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Indicated for primary total knee arthroplasty
Home discharge post-operatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-surgery
Awards & highlights

Study Summary

This trial will compare two methods of rehabilitation after total knee arthroplasty (TKA) to see if a new, validated, wearable smart knee brace is noninferior to regular PT.

Who is the study for?
Adults aged 18-100 who need a total knee replacement and can go home after surgery. They must have a smartphone to use with the FM2 Knee Brace app. People with a BMI over 40, previous knee surgeries, or manipulation under anesthesia are not eligible.Check my eligibility
What is being tested?
This study is comparing two ways to recover from knee replacement surgery: traditional outpatient physical therapy versus using a smart knee brace called FM2. Participants will be randomly placed in one of these two groups and followed up for one year.See study design
What are the potential side effects?
While the trial primarily focuses on rehabilitation methods rather than medications, potential side effects may include discomfort or skin issues related to wearing the FM2 Knee Brace.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am recommended to have a total knee replacement.
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I will be discharged to my home after surgery.
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I am between 18 and 100 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Range of Motion

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Smart Orthotic Device (FM2 Knee Brace)Experimental Treatment1 Intervention
Group II: Outpatient Physical TherapyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Scott MufflyLead Sponsor
Nicolas Noiseux, MD FRCSCLead Sponsor

Media Library

FM2 Knee Brace Clinical Trial Eligibility Overview. Trial Name: NCT04924205 — N/A
Knee Arthropathy Research Study Groups: Outpatient Physical Therapy, Smart Orthotic Device (FM2 Knee Brace)
Knee Arthropathy Clinical Trial 2023: FM2 Knee Brace Highlights & Side Effects. Trial Name: NCT04924205 — N/A
FM2 Knee Brace 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924205 — N/A
~10 spots leftby Dec 2024
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