RecruitingNot ApplicableNCT06968143

Investigating Patient Satisfaction With Smart Knee Implants

Evaluating the Impact of Remote Therapeutic Monitoring on Knee Arthroplasty Recovery

Sponsor

University of Chicago

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Total Knee Arthroplasty

Summary

The main goal of this study is to see if there is a connection between the social and economic resources available in a patient's neighborhood (measured by the Area Deprivation Index, ADI) and their recovery after knee replacement surgery, as tracked through remote monitoring. A secondary goal is to find out if patients' self-reported pain and function score are linked to their actual physical improvement after surgery as measured by a remote therapeutic monitoring (RTM) device. Additionally, this study examines whether RTM can reduce the number of postoperative clinic visits within the first 90 days after surgery while maintaining patient satisfaction and patient-reported outcome measures (PROMs).

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Patients over 18 years of age
Patients undergoing unilateral primary or revision total knee arthroplasty with the smart knee implant or standard-of-care

Exclusion Criteria2

Patients who receive contralateral knee replacement or contralateral or unilateral hip replacement within 90 days before or after their knee replacement in this study
Patients with post-operative weight-bearing restrictions or physical deconditioning prohibiting routine physical therapy participation

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Interventions

DEVICESmart Knee Implant

An important advancement in objective recovery data occurred when the first ever 'smart' knee implant for remote therapeutic monitoring (RTM) after total knee arthroplasty (TKA) was released in 2021. The implant includes both a prosthesis for TKA and a stem, the latter of which records the following metrics: step count, distance traveled, tibial range-of-motion (ROM), functional ROM, average walking speed, stride length, and cadence. The implant sends the recordings to a mobile platform. Additionally, it collects and analyzes patient across the entire population of users and creates percentiles for each metric based on patient age, gender and time since surgery. These "recovery curves" provide more objective data for practitioners and patients to evaluate recovery progress and make adjustments to their care plans accordingly.