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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-surgery

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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals under 35 years of age admissible to this experiment?

"Eligibility for this medical trial requires participants to be at least 18 years of age and, conversely, no older than 100."

Answered by AI

What is the minimum number of participants needed to make this clinical trial successful?

"Correct. Records on clinicaltrials.gov indicate that this medical experiment, which was first posted in September 2021, is actively recruiting participants. 80 individuals need to be recruited from a single facility."

Answered by AI

Is this experiment still accessible to participants?

"This clinical trial, which has been listed on clinicaltrials.gov since September 1st 2021, is still actively seeking participants. The listing was last updated on June 20th 2022."

Answered by AI

Is it possible to join this clinical research initiative?

"This trial seeks 80 people with arthropathy of the knee, aged 18 to 100. Eligibility criteria includes: meeting age requirements; owning a smartphone compatible with FocusMotion and FM2 Knee Brace applications; and being able to discharge oneself post-operatively from home."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nicolas Noiseux, MD FRCSC 2021. "A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04924205.