TracPatch in Total Knee Arthroplasty

NCT03466476 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-30

No results posted yet for this study

Summary

Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.

Conditions

  • Arthroplasty, Replacement, Knee
  • Osteoarthritis, Knee

Interventions

DEVICE

Consensus TracPatch

Consensus TracPatch will be attached to the participant's shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage for 6 weeks after total knee arthroplasty.

Sponsors & Collaborators

  • Consensus Orthopedics

    collaborator UNKNOWN
  • University of Miami

    lead OTHER

Principal Investigators

  • Victor Hernandez · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2026-06-01
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466476 on ClinicalTrials.gov