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Investigating Patient Satisfaction With Smart Knee Implants

NCT06968143 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Sara Wallace, MD · The University of Chicago Department of Orthopaedic Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-04-30
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968143 on ClinicalTrials.gov