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Active, Not Recruiting

NCT Number: NCT03466476

TracPatch in Total Knee Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthroplasty, Replacement, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical candidate for total knee arthroplasty
  • Greater than 18 years of age
  • Have signed the written informed consent form
  • Have consistent access to an iOS or Android device with Bluetooth capability

Exclusion criteria

  • Unwilling or unable to provide consent
  • Not fluent in the language of the informed consent form (English and Spanish)
  • Prisoners
  • Pregnant women
  • Wards of the state
  • Have previously undergone a TKA on that ipsilateral knee
  • Deformities of > 10 degrees valgus or varus or flexion contractures of > 10 degrees.
  • Considered by the surgeon to be a complex arthroplasty

Treatment and study plan

Consensus TracPatch

Device

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.

Primary outcomes

  1. Range of Motion

    Time frame: Up to 6 weeks after surgery

    Range of motion, including flexion and extension of the knee will be measured with a goniometer in degrees.

    Measured in degrees, the patients range of motion in the operative knee will be measured before surgery and continuously by the TracPatch monitor up to six weeks post-operatively.

Secondary outcomes

  1. Patient-Reported Outcome Measurement Information System (PROMIS)

    Time frame: Up to 6 weeks after surgery

    The PROMIS is a 10-question survey that assesses patient's overall functional status and ability to accomplish activities of daily living. It has a total score ranging from 9-55 with 9 indicating poor functional status.

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)

    Time frame: Up to 6 weeks after surgery

    The KOOS Jr. is a standardized scoring system developed to rate both the knee prosthesis function and the patient's functional abilities after total knee arthroplasty. It has a total score ranging from 0-100 with 0 indicating more severe symptoms.

  3. Visual Analogue Score

    Time frame: Up to 6 weeks after surgery

    A rating system from 1 - 10 developed to assess the patient's subjective rating of pain. A higher score indicates worse pain.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Consensus Orthopedics

Registry information

Official study title

Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty (TKA)

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2018
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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