Investigating Patient Satisfaction With Smart Knee Implants

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06968143
• Lead Sponsor: University of Chicago

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-10
• Primary Completion: 2027-04-30
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes and Satisfaction	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 Outcome Measures

Name	Time	Method
Area Deprivation Index Correlation with Recovery	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.
Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles	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.
Complications after Knee Arthroplasty	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.

Trial Locations

Locations (1)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States