Investigating Patient Satisfaction With Smart Knee Implants

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06968143
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Sep 1, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical CenterChicagoIllinois60637
Sara Wallace, MD
[email protected]
773-834-3531

Find similar trials in Chicago, IL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
The University of Chicago Medical Center· Chicago, IL

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