ClinicalTrials.Veeva

Menu

TracPatch in Total Knee Arthroplasty

University of Miami logo

University of Miami

Status

Active, not recruiting

Conditions

Arthroplasty, Replacement, Knee
Osteoarthritis, Knee

Treatments

Device: Consensus TracPatch

Study type

Interventional

Funder types

Other

Identifiers

NCT03466476
20171099
20220990

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Wearable Technology Group
Experimental group
Description:
Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.
Treatment:
Device: Consensus TracPatch
Current Standard of Care Group
No Intervention group
Description:
Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems