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

Launched by NICOLAS NOISEUX, MD, MS, FRCSC · Jun 10, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to help patients recover after total knee replacement surgery (known as TKA). One group of participants will receive traditional outpatient physical therapy, which involves visiting a therapist for six weeks to help regain strength and movement in their knee. The other group will use a new, wearable smart knee brace called the FM2 Knee Brace, which allows them to do exercises at home on their own schedule. The goal is to see if this smart brace is just as effective as regular physical therapy for helping patients recover.

To be eligible for the trial, participants must be adults aged 18 to 100 who are set to have a total knee replacement surgery and have a smartphone to use a special app with the brace. Participants will be randomly assigned to one of the two groups and will be monitored throughout their recovery, with check-ins at different points after surgery to assess their knee movement and overall progress. This study aims to find out if the smart knee brace could be a good alternative to standard therapy for knee surgery recovery.

Gender

ALL

Eligibility criteria

  • 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

About Nicolas Noiseux, Md, Ms, Frcsc

Dr. Nicolas Noiseux, MD, MS, FRCSC, is a distinguished clinical trial sponsor and a leading figure in the field of surgical research. With extensive training and expertise in surgical oncology, Dr. Noiseux is committed to advancing medical knowledge through innovative clinical trials aimed at improving patient outcomes. His comprehensive understanding of complex surgical procedures, combined with a strong emphasis on evidence-based practices, positions him as a pivotal contributor to the development of new therapeutic strategies. Dr. Noiseux's dedication to patient-centered research and collaboration with multidisciplinary teams underscores his role in driving forward the frontiers of surgical science.

Locations

Iowa City, Iowa, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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