Smart Knee Implants for Osteoarthritis

Overseen By Malik J Scott, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Contralateral knee/hip replacement, Weight-bearing restrictions, Physical deconditioning

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Sara Wallace, MD

Principal Investigator

The University of Chicago Department of Orthopaedic Surgery

Eligibility Criteria

This trial is for individuals with osteoarthritis who are undergoing or have undergone knee replacement surgery. It aims to include a diverse group of patients from various socioeconomic backgrounds, as indicated by the Area Deprivation Index.

Inclusion Criteria

I am over 18 years old.

I am having knee replacement surgery with a smart knee implant or standard option.

Exclusion Criteria

I can't do regular physical therapy due to surgery-related movement limits or weakness.

I had or will have hip or other knee surgery around the time of this knee replacement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo knee arthroplasty and begin initial recovery, including monitoring with smart knee implants for those in the experimental group

12 weeks

Regular postoperative visits as per standard care

Remote Therapeutic Monitoring

Participants use remote therapeutic monitoring devices to track recovery metrics such as range-of-motion and step count

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient-reported outcomes and satisfaction surveys

up to 1 year

Follow-up assessments at multiple timepoints

Treatment Details

Interventions

• Smart Knee Implant

Trial Overview The study tests if a Smart Knee Implant, combined with remote monitoring, can track recovery and improve outcomes after knee replacement. It also explores whether this technology reduces clinic visits while keeping patients satisfied.

Participant Groups

Group I: Smart Knee Implant Experimental Treatment 1 Intervention

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.

Group II: Standard-of-Care Knee Arthroplasty Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+