Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06968143

Investigating Patient Satisfaction With Smart Knee Implants

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Sara Wallace, MD

CONTACT

[email protected]

773-834-3531

About this study

Predicting and measuring knee function after total knee arthroplasty (TKA) has been a topic of debate in the field of orthopedic surgery for decades. The early recovery period after TKA is a critical time for achieving functional range of motion and mobility. For this reason, patients are traditionally examined at regular intervals during the postoperative period for evaluation. For patients who are not meeting targets during early recovery, interventions such as manipulation under anesthesia (MUA) or modifications to physical therapy protocols can improve outcomes. Remote therapeutic monitoring (RTM) using smart knee implants has been proposed as a means of enhancing postoperative follow-up with increased convenience to patients and without overburdening ambulatory resources. These smart knee implants collect objective recovery data including range-of-motion (ROM), step count, and cadence, and send these metrics to a mobile application so that patients and their practitioners can track their progress outside of the medical space. This study aims to compare post-operative patient-reported outcomes and satisfaction at multiple timepoints between patients with RTM and those with the current standard-of-care.

Insight into patient's functional recovery in their post-operative home environment may help orthopedic surgeons to better understand the impact of the social determinants of health (SDOH) on recovery. One of the methods of quantifying SDOH that has been popular in the healthcare field is the Area Deprivation Index (ADI). ADI was developed by the University of Wisconsin-Madison and uses patient addresses to display percentile-based information about neighborhood resources (including income, education, employment, and housing quality), quantifying healthcare accessibility. Some studies have found that while higher ADI may predict medical complications, non-home discharge, length of stay, and 90-day emergency department visits, there is low to no evidence that the metric is correlated with postoperative readmission rates, reoperation rates, or range of motion (ROM).Therefore, investigation into ADI as a predictor of outcomes following TKA needs to be further studied, particularly in juxtaposition with objective metrics of recovery.

The primary objective of this study is therefore to delineate if there is a correlation between the SDOH resources available to patients based on their home environment as measured by ADI, and remotely monitored functional outcomes after TKA . The secondary objective is to determine if patient-reported pain and function scores as measured by Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) correlate with remotely monitored functional improvement after TKA. The tertiary objective is to determine how patient satisfaction with surgery and postoperative recovery compares between patients with RTM and patients with standard knee replacements.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Knee Implant

Device

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.

Other names: Persona IQ

Primary outcomes

  1. Patient-Reported Outcomes and Satisfaction

    Time frame: From enrollment to 1 year after arthroplasty

    The patients in both arms will complete surveys on their subjective pain and function as well as their subjective satisfaction with the knee arthroplasty preparation, surgery, and recovery. The investigators will compare these surveys between the experimental group and the standard-of-care group at select time points.

Secondary outcomes

  1. Area Deprivation Index Correlation with Recovery

    Time frame: up to 1 year

    The investigators will be retrospectively collecting patient records that will include patient neighborhood locations to calculate an Area Deprivation Index (ADI) score. These patients will be those who have received the smart knee implant before this study was approved, and the investigators will evaluate the correlation between smart knee implant recovery curve percentiles and the Area Deprivation Index in patients receiving the smart knee implant. A high Area Deprivation Index means being more socioeconomically deprived, and the scale is scored from 0 to 100.

  2. Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles

    Time frame: From enrollment to 1 year after arthroplasty

    The investigators will collect the Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles for the patients that receive smart knee implants and will calculate correlation scores between them. The KOOS, JR. is scored from 0 to 100 and a higher score means better knee function.

  3. Complications after Knee Arthroplasty

    Time frame: From enrollment to 1 year after arthroplasty

    The investigators will record the rate of patients requiring assistive walking devices, revision arthroplasty, manipulation under anesthesia, and the rates of periprosthetic joint infection between patients who receive smart knee implants and the standard-of-care joint arthroplasty.

Study contacts

Contact information is provided by the study sponsor or research team.

Malik J Scott, BA

CONTACT

[email protected]

773-834-0822

Vincent Buckman, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Evaluating the Impact of Remote Therapeutic Monitoring on Knee Arthroplasty Recovery

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.