TracPatch in Total Knee Arthroplasty

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Knee; Arthroplasty, Replacement, Knee
• Interventions: Device: Consensus TracPatch

• Registration Number: NCT03466476
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wearable Technology Group	Consensus TracPatch	Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Primary Outcome Measures

Name	Time	Method
Range of Motion	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 Outcome Measures

Name	Time	Method
Visual Analogue Score	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)	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.
Patient-Reported Outcome Measurement Information System (PROMIS)	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.

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States