TracPatch in Total Knee Arthroplasty

NCT03466476 | Active Not Recruiting FDA Device

• 2 other identifiers: 2022099020171099
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Keywords

Wearable Technology; Total Knee Arthroplasty; Accelerometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient-Reported Outcome Measurement Information System (PROMIS)

  Up to 6 weeks after surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)

  Up to 6 weeks after surgery

• Visual Analogue Score

  Up to 6 weeks after surgery

Study Arms (2)

Wearable Technology Group

EXPERIMENTAL

Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Device: Consensus TracPatch

Current Standard of Care Group

NO INTERVENTION

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.

Interventions

Consensus TracPatch DEVICE

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.

Wearable Technology Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Consensus Orthopedics: collaborator

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Related Publications (4)

• 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.

  PMID: 26842273 BACKGROUND

• 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.

  PMID: 17589828 BACKGROUND

• 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.

  PMID: 24117351 BACKGROUND

• 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.

  PMID: 25868424 BACKGROUND

Related Links

• Device website available to public

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Victor Hernandez

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Arthroplasty & Joint Reconstruction

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 15, 2018
• Study Start: March 20, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)