Clinical trial NCT03466476: TracPatch in Total Knee Arthroplasty
Official title: Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Osteoarthritis, Knee
Keywords: Wearable Technology
Total Knee Arthroplasty
Accelerometer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Consensus Orthopedics
First posted: 2018-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who meet enrollment criteria will be randomized to either the treatment group where they will receive their consensus tracpatch or be assigned to the control group where no wearable technology will be employed.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Range of Motion
timeFrame: Up to 6 weeks after surgery
Secondary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS)
timeFrame: Up to 6 weeks after surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
timeFrame: Up to 6 weeks after surgery
measure: Visual Analogue Score
timeFrame: Up to 6 weeks after surgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Victor Hernandez
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.