Investigating Patient Satisfaction With Smart Knee Implants

NCT06968143 | Recruiting FDA Device

• 1 other identifier: IRB25-0508
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Total Knee Arthroplasty; Knee Replacement; Knee Replacement Arthroplasty; Knee Osteoarthritis

Keywords

Smart Knee Implant; Total Knee Arthroplasty; Remote Therapeutic Monitoring; Persona IQ

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Outcomes and Satisfaction

  The patients in both arms will complete surveys on their subjective pain and function as well as their subjective satisfaction with the knee arthroplasty preparation, surgery, and recovery. The investigators will compare these surveys between the experimental group and the standard-of-care group at select time points.

  From enrollment to 1 year after arthroplasty

Secondary Outcomes (3)

• Area Deprivation Index Correlation with Recovery

  up to 1 year

• Correlation between Knee Injury and Osteoarthritis Outcome score for Joint Replacement (KOOS, JR.) and smart knee implant recovery curve percentiles

  From enrollment to 1 year after arthroplasty

• Complications after Knee Arthroplasty

  From enrollment to 1 year after arthroplasty

Study Arms (2)

Smart Knee Implant

EXPERIMENTAL

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.

Device: Smart Knee Implant

Standard-of-Care Knee Arthroplasty

NO INTERVENTION

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

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.

Also known as: Persona IQ

Smart Knee Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients undergoing unilateral primary or revision total knee arthroplasty with the smart knee implant or standard-of-care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (11)

• Yocum D, Housholder E, Yergler J. Manipulation under Anesthesia Following TKA with Persona IQ: A Case Series. J Orthop Case Rep. 2023 Aug;13(8):127-131. doi: 10.13107/jocr.2023.v13.i08.3844.

  PMID: 37654748 BACKGROUND

• Yocum D, Elashoff B, Verta P, Armock G, Yergler J. Patient reported outcomes do not correlate to functional knee recovery and range of motion in total knee arthroplasty. J Orthop. 2023 Jul 27;43:36-40. doi: 10.1016/j.jor.2023.07.009. eCollection 2023 Sep.

  PMID: 37564705 BACKGROUND

• Shimizu MR, Buddhiraju A, Lin-Wei Chen T, Huang Z, Chen SF, Xiao P, RezazadehSaatlou M, Kwon YM. Socioeconomic area deprivation index is not associated with postoperative complications following revision total hip and knee joint arthroplasty. J Orthop. 2024 Jul 17;58:135-139. doi: 10.1016/j.jor.2024.07.008. eCollection 2024 Dec.

  PMID: 39100544 BACKGROUND

• Calkins FM, Pagani NR, Bragg J, Gauthier Z, Salzler M. Neighborhood socioeconomic disadvantage does not predict need for manipulation under anesthesia or range of motion following total knee arthroplasty. J Orthop. 2024 Jun 15;58:146-149. doi: 10.1016/j.jor.2024.06.013. eCollection 2024 Dec.

  PMID: 39100542 BACKGROUND

• Jevnikar BE, Huffman N, Roth A, Klika AK, Deren ME, Zhang C, Piuzzi NS; CCARR Corporate Authorship. Impacts of neighborhood deprivation on septic and aseptic revision total knee arthroplasty outcomes: A comprehensive analysis using the area deprivation index. Knee. 2024 Dec;51:74-83. doi: 10.1016/j.knee.2024.08.006. Epub 2024 Sep 5.

  PMID: 39241673 BACKGROUND

• Shimizu MR, Buddhiraju A, Kwon OJ, Kerluku J, Huang Z, Kwon YM. The Utility of Neighborhood Social Vulnerability Indices in Predicting Non-Home Discharge Disposition Following Revision Total Joint Arthroplasty: A Comparison Study. J Arthroplasty. 2025 May;40(5):1148-1153. doi: 10.1016/j.arth.2024.10.118. Epub 2024 Oct 25.

  PMID: 39490785 BACKGROUND

• Gordon AM, Ng MK, Elali F, Piuzzi NS, Mont MA. A Nationwide Analysis of the Impact of Socioeconomic Status on Complications and Health Care Utilizations After Total Knee Arthroplasty Using the Area Deprivation Index: Consideration of the Disadvantaged Patient. J Arthroplasty. 2024 Sep;39(9):2166-2172. doi: 10.1016/j.arth.2024.04.028. Epub 2024 Apr 12.

  PMID: 38615971 BACKGROUND

• Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant n.d. http://investor.zimmerbiomet.com/news-and-events/news/2021/08-30-2021-120155075 (accessed December 12, 2024).

  BACKGROUND

• Hsu H, Siwiec RM. Knee Arthroplasty(Archived). 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507914/

  PMID: 29939691 BACKGROUND

• Bourne RB. Measuring tools for functional outcomes in total knee arthroplasty. Clin Orthop Relat Res. 2008 Nov;466(11):2634-8. doi: 10.1007/s11999-008-0468-0. Epub 2008 Sep 9.

  PMID: 18780136 BACKGROUND

• Yoshida Y, Zeni J, Snyder-Mackler L. Do patients achieve normal gait patterns 3 years after total knee arthroplasty? J Orthop Sports Phys Ther. 2012 Dec;42(12):1039-49. doi: 10.2519/jospt.2012.3763. Epub 2012 Oct 22.

  PMID: 23090437 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sara Wallace, MD

  The University of Chicago Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malik J Scott, BA

CONTACT

773-834-0822; mjscott1@uchicago.edu

Vincent Buckman, BS

CONTACT

vincent.buckman@uchicagomedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be receiving, by their choice, either the smart knee implant, or the standard-of-care total knee arthroplasty. The two groups will have the same pre- and post-operative follow-up, except the smart knee implant group will be able to track their progress through a mobile application and see how they compare in their metrics against others of the same age and gender. Patients in both groups will complete the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) at their pre-operative, 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments, and will also complete satisfaction surveys at their 6-week post-operative, 90-day post-operative, and 1-year post-operative appointments. The investigators will compare KOOS, JR. scores between the two groups and the investigators will also compare satisfaction scores between the smart knee implant and standard-of-care groups.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)