Safety and Performance of Journey II XR Total Knee System (JIIXR)

Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study

The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.

Study Overview

• Status: Completed
• Conditions: Journey II XR Total Knee System
• Intervention / Treatment: Device: Journey II XR TKA

• Study Type: Observational
• Enrollment (Actual): 683

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Orthopedic Institute of the West
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Rush Copley Orthopaedics
  • Michigan
    • Port Huron, Michigan, United States, 48060
      • Jerry Orthopaedic Institute
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthopedic Clinic
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Orthopaedic Center of New Jersey
  • New York
    • New York, New York, United States, 10003
      • Hospital for Joint Diseases Orthopaedics Institute
  • Oregon
    • Oregon City, Oregon, United States, 97045
      • Regenerative Orthopedic Center (ROC)
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • San Antonio, Texas, United States, 78258
      • San Antonio Orthopaedic Specialists
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Anderson Orthopaedic Clinic
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • Scott Orthopedic Center
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Aurora Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication

Description

Inclusion Criteria:

• Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
• The TKA occurred at least 12 weeks prior to enrollment.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision of one or more study device components	Measure of the number of revision cases	12 weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization: Hospitalization	Length of hospital stay for primary (index) surgery	implantation through study completion, approximately 3 years
Adverse Events	All collected and reported AEs	12 weeks follow up
Health care utilization: Hospitalization	Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)	Implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation	number of sessions and duration of rehabilitation in weeks	Implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits	Number and type of outpatient visits	Implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations	Number of re-operations and revisions	Implantation through study completion, approximately 3 years
Quality of Life: EQ-5D-3L	EuroQol Five Dimensions Questionnaire	Implantation through study completion, approximately 3 years
Quality of Life: KSS	2011 Knee Society Score	Implantation through study completion, approximately 3 years
Return to Work	Changes in employment status will be recorded with the date on which the change occurred and the change status.	Implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation	Number of technical difficulties encountered with the device	Implantation through study completion, approximately 3 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Collaborators: Nor Consult, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Journey II XR Total Knee System
• Other Study ID Numbers: JIIXR.PMCF.2018.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes