TracPatch in Total Knee Arthroplasty
Study Details
Study Description
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 in the general population. 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 allow the surgeon and patient to monitor recovery and help ensure critical milestones are being met. Our hypothesis is that this new technology will improve patient outcomes as it pertains to rehabilitation milestones and overall satisfaction as compared to controls who do not utilize this technology.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wearable Technology Patients in this arm will be provided with their own Consensus TracPatch wearable device as well as instructions on its use. |
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.
The information gained by the TracPatch wearable technology will be readily available via a HIPAA secure system to the surgeon and patient in order to monitor post-operative recovery and signal to both parties if any intervention is indicated. The device also monitors for rapid acceleration events which may indicate a traumatic injury. Additionally, the temperature sensor may help detect sub-clinical infection.
|
| No Intervention: Current Standard Patients in this arm will not be provided with any wearable device. |
Outcome Measures
Primary Outcome Measures
- Range of Motion [6 weeks after surgery]
Flexion and extension of the knee will be measured with a goniometer in degrees, the sum of which will determine range of motion. Measured in degrees, the patients range of motion in the operative knee will be measured before surgery, at the 2-week post operative visit and the 6-week post operative visit.
Secondary Outcome Measures
- Oxford Knee Score [6 weeks after surgery]
The Oxford Knee Score (OKS) with a total range of 0- 48 with a lower score indicating more severe symptoms. OKS is a 12-item patient reported outcome score designed to assess function and pain after total knee replacement.
- Knee Society Score (KSS) [6 weeks after surgery]
The Knee Society Score is a standardized scoring system developed to rate both the knee prosthesis function and the patient's functional abilities after total knee arthroplasty. The KSS has a total score ranging from 0-100 with 0 indicating more severe symptoms.
- Visual Analogue Score [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Surgical candidate for total knee arthroplasty
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Greater than 18 years of age
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Have signed the written informed consent form
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Have consistent access to an iOS or Android device with Bluetooth capability
Exclusion Criteria:
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Patients not fluent in the language of the informed consent form
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Prisoners
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Pregnancy
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Reported to have mental illness or belonging to a vulnerable population
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Have previously undergone a TKA on that same knee
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Deformities of more than 10 degrees on either valgus or varus or flexion contractures of more than 10 degrees.
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Considered by the surgeon to be complex arthroplasty
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami Hospital | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- Consensus Orthopedics
Investigators
- Principal Investigator: Victor Hernandez, University of Miami
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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. Epub 2007 Jun 23.
- 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.
- 20171099