Smart knee implants and patient satisfaction after knee replacement
Evaluating the Impact of Remote Therapeutic Monitoring on Knee Arthroplasty Recovery
This study will see if smart knee implants that send recovery data can help people recover, stay satisfied, and reduce clinic visits after knee replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06968143 on ClinicalTrials.gov |
What this trial studies
This interventional study compares patients who receive a smart knee implant that streams range-of-motion, step count, and cadence to a mobile app with patients receiving standard postoperative care. Investigators will link these objective recovery metrics to patient-reported pain and function scores at multiple timepoints and analyze whether neighborhood socioeconomic status measured by the Area Deprivation Index predicts recovery. The study will also test whether remote therapeutic monitoring can reduce the number of postoperative clinic visits within the first 90 days while preserving satisfaction and PROMs. Participants are adults undergoing unilateral primary or revision total knee arthroplasty at the University of Chicago and will be followed through early postoperative recovery.
Who should consider this trial
Good fit: Adults undergoing unilateral primary or revision total knee arthroplasty who can participate in routine physical therapy and engage with remote monitoring are ideal candidates.
Not a fit: Patients with postoperative weight-bearing restrictions, those unable to participate in routine physical therapy, or those having another lower-extremity joint replacement within 90 days are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, this approach could personalize follow-up, reduce unnecessary clinic visits, and help catch early problems to improve recovery after knee replacement.
How similar studies have performed: Wearable and remote-monitoring programs in orthopedics have shown promise for tracking recovery, but embedded smart knee implants are relatively new and have limited published outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Sara Wallace, MD — The University of Chicago Department of Orthopaedic Surgery
- Study coordinator: Malik J Scott, BA
- Email: mjscott1@uchicago.edu
- Phone: 773-834-0822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.