TracPatch in Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03466476
• Other study ID #: 20220990
• Secondary ID: 20171099
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Consensus Orthopedics

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arosha Senanayake SM, Ahmed Malik O, Mohammad Iskandar P, Zaheer D. Assessing post-anterior cruciate ligament reconstruction ambulation using wireless wearable integrated sensors. J Med Eng Technol. 2013 Nov;37(8):498-510. doi: 10.3109/03091902.2013.837529. Epub 2013 Oct 14. — View Citation

Belsi A, Papi E, McGregor AH. Impact of wearable technology on psychosocial factors of osteoarthritis management: a qualitative study. BMJ Open. 2016 Feb 3;6(2):e010064. doi: 10.1136/bmjopen-2015-010064. — View Citation

Kleijn LL, van Hemert WL, Meijers WG, Kester AD, Lisowski L, Grimm B, Heyligers IC. Functional improvement after unicompartmental knee replacement: a follow-up study with a performance based knee test. Knee Surg Sports Traumatol Arthrosc. 2007 Oct;15(10):1187-93. doi: 10.1007/s00167-007-0351-7. Epub 2007 Jun 23. — View Citation

Kwasnicki RM, Ali R, Jordan SJ, Atallah L, Leong JJ, Jones GG, Cobb J, Yang GZ, Darzi A. A wearable mobility assessment device for total knee replacement: A longitudinal feasibility study. Int J Surg. 2015 Jun;18:14-20. doi: 10.1016/j.ijsu.2015.04.032. Epub 2015 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	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.	Up to 6 weeks after surgery
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS)	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.	Up to 6 weeks after surgery
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)	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.	Up to 6 weeks after surgery
Secondary	Visual Analogue Score	A rating system from 1 - 10 developed to assess the patient's subjective rating of pain. A higher score indicates worse pain.	Up to 6 weeks after surgery

External Links

•   Device website available to public