Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06968143

Conditions

Total Knee Arthroplasty

Knee Replacement

Knee Replacement Arthroplasty

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Smart Knee Implant

Study Details

Brief 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).

Conditions

Total Knee Arthroplasty

Knee Replacement

Knee Replacement Arthroplasty

Knee Osteoarthritis

Study ID

NCT06968143

Start date

Sep 1, 2025

Status verified date

Dec, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smart Knee Implant

This group will receive the smart knee implant during their arthroplasty and will be able to track their progress according to the smart metrics through a mobile application, and will otherwise have the same standard-of-care as the other arm.

no intervention: Standard-of-Care Knee Arthroplasty

This arm includes patients who are receiving the standard-of-care knee arthroplasty and will have standard follow-up with their surgeons.

Interventions

Smart 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.

Primary outcome measure

  • Patient-Reported Outcomes and Satisfaction [ Time Frame: From enrollment to 1 year after arthroplasty ]

Central Contacts and Locations

Central contacts

Malik J Scott, BA

773-834-0822mjscott1@uchicago.edu

Vincent Buckman, BS

vincent.buckman@uchicagomedicine.org

Locations

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sara Wallace, MD

773-834-3531swallace2@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Smart Knee Implant
  • Total Knee Arthroplasty
  • Remote Therapeutic Monitoring
  • Persona IQ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-17.