Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS) (JIICR)

Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study

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

Study Overview

• Status: Completed
• Conditions: Journey II CR Total Knee System
• Intervention / Treatment: Device: Total knee arthroplasty with Journey II CR Total Knee System

• Study Type: Observational
• Enrollment (Actual): 586

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Orthopaedic Specialists of Scottsdale
  • Kentucky
    • Pikeville, Kentucky, United States, 41501
      • Pikeville Medical Center
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthopedic Institute
  • New York
    • New York, New York, United States, 10003
      • New York University
  • Ohio
    • New Albany, Ohio, United States, 43054
      • OrthoNeuro
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Tennessee Orthopaedic Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.

Description

Inclusion Criteria:

• Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an 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	Time Frame
Number of adverse events reported per ISO 14155 guidelines	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay for primary (index) surgery		7 years
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery		7 years
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery		upon occurence through 7 years of study duration
Number of rehabilitation sessions		7 years
Duration of rehabilitation sessions in weeks		7 years
Number and type of outpatient visits		7 years
Number of re-operations		7 years
Quality of Life as measured by EQ-5D-3L score	The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	7 years
Patient Pain Level as measured by Knee Society Score (KSS)	Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities.	7 years
Number of days before return to work		7 years
Number of technical difficulties encountered with the device		7 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Collaborators: Nor Consult
• Investigators: Study Chair: Sandra Navarrete, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Journey II CR Total Knee System
• Other Study ID Numbers: 2018.19.KNE.JIICR.RET

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: No