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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how neighborhood resources might affect recovery after knee replacement surgery. It also examines whether a smart knee implant, which tracks recovery through an app, aligns with patients' perceptions of pain and function. Additionally, the trial assesses if this smart technology can reduce the number of follow-up visits needed after surgery. Ideal candidates for this trial are those undergoing a single knee replacement, with no other recent or upcoming major joint surgeries. As an unphased trial, this study offers patients the chance to contribute to innovative research that could improve recovery experiences for future knee replacement patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Smart Knee Implant is safe for patients with osteoarthritis?

Research shows that smart knee implants contain sensors to monitor recovery after surgery. These sensors provide real-time information, enabling doctors to detect problems early and adjust treatment as needed. Studies suggest that patients generally tolerate these implants well, with no major safety issues reported. Although still under study, this technology appears promising for making knee replacement surgeries safer and more personalized. Prospective trial participants may find this information reassuring regarding the safety of the smart knee implant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Smart Knee Implant is unique because it incorporates advanced technology to enhance the standard knee arthroplasty. Unlike traditional knee replacements, which focus solely on replacing the joint, this implant includes smart metrics that patients can track via a mobile app. This allows for real-time monitoring of recovery and personalized insights, potentially leading to better outcomes and more informed care. Researchers are excited about this innovation because it offers a more interactive and precise approach to managing osteoarthritis post-surgery, setting it apart from current treatments that lack this digital enhancement.

What evidence suggests that the Smart Knee Implant is effective for osteoarthritis?

This trial will compare smart knee implants with standard-of-care knee arthroplasty. Research has shown that smart knee implants, which participants in this trial may receive, provide real-time information after knee replacement surgery, aiding patients and doctors in tracking recovery. These implants have improved patient outcomes and satisfaction, though further research is needed to understand long-term benefits. Early studies demonstrated that smart knee implants can successfully monitor knee function and assist with physical therapy by tracking joint movement and pressure. Patients reported significant improvements in knee function and overall recovery. This technology offers a new way to enhance recovery by providing ongoing insights into knee health. ^{2 4 6 7 8}

Who Is on the Research Team?

Sara Wallace, MD

Principal Investigator

The University of Chicago Department of Orthopaedic Surgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40037527/

Smart Knee Implants and Functional Outcome for Total ... Preliminary studies demonstrate favorable patient outcomes and satisfaction, although further research is necessary to establish the long-term ...

2. rothmanortho.com rothmanortho.com/stories/blog/how-sensor-enabled-smart-knee-implants-are-changing-joint-replacement

How Sensor-Enabled Smart Knee Implants Are Changing ... These work to provide real-time data following knee replacement surgery and allows for postoperative recovery tracking technology.

3. uchicagomedicine.org uchicagomedicine.org/forefront/orthopaedics-articles/2025/february/smart-knee-replacement-tracks-patient-progress

'Smart knee' replacement tracks patient progress, data to ... The implant tracks the effectiveness of a patient's physiotherapy program, and it continues to monitor a wearer's knee function for years to come.

4. mdpi.com mdpi.com/2411-9660/9/4/93

Investigating Smart Knee Implants The implants are effective in restoring function without feedback in real time on joint motion, pressure distribution, or implant wear. Smart knee implants, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540324005783

Evaluating Knee Recovery Beyond Patient Reports: A ... This study indicates that both PROMs and SID gait metrics show significant improvements post-TKA, though they correlate weakly with each other.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10147863/

“Smart Knee Implants: An Overview of Current ... This article focuses on clinical implementation of smart knee implants for total knee replacement and the future development of smart implant technology.

7. zimmerbiomet.com zimmerbiomet.com/en/patients-caregivers/knee-replacement-implants-technologies/Persona-IQ-smart-knee.html

Persona IQ ® The Smart Knee ® Implant A highly personalized knee with a smart stem extension that contains sensors to collect motion data after your knee replacement surgery.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566221004896

Smart sensor implant technology in total knee arthroplasty A successful outcome in TKA is broadly dependent on three factors: patient dependant factors, surgical technique, and implant design [Fig. 1]. Patient dependant ...