NCT03466476

TracPatch in Total Knee Arthroplasty

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-03-20
• Primary completion: 2026-06-01
• Completion: 2026-06-30
• First posted: 2018-03-15
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study