Investigating Patient Satisfaction With Smart Knee Implants

The University of Chicago

Status: Begins enrollment in 2 months

Conditions: Knee Replacement Arthroplasty; Knee Replacement; Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Device: Smart Knee Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06968143

IRB25-0508

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Smart Knee Implant

Experimental group

Description:

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.

Treatment:

Device: Smart Knee Implant

Standard-of-Care Knee Arthroplasty

No Intervention group

Description:

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