Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study

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

The objective of this study is to estimate the safety and performance of Journey II BCS TKS.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Journey II BCS Total Knee System

Detailed Description

The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.

• Study Type: Observational
• Enrollment (Actual): 1694

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium
    • Jesse Ziekenhuis
  • Pellenberg, Belgium
    • UZ Leuven Campus
• Switzerland
  • Bern, Switzerland
    • Christen Ortho AG
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Orthopaedics
  • Florida
    • Gulf Breeze, Florida, United States, 32571
      • Andrews Research and Education Foundation
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Methodist Sports Medicine
  • New York
    • New York, New York, United States
      • Hospital for Special Surgery
  • Pennsylvania
    • State College, Pennsylvania, United States, 16602
      • University Orthopaedics Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • TN Orthopaedic Foundation for Education and Research
  • Texas
    • San Antonio, Texas, United States, 78258
      • San Antonio Orthopaedic Specialists
  • Washington
    • Everett, Washington, United States, 98021
      • Providence Regional Medical Center
  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Marra Knee and Shoulder Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.

Description

Inclusion Criteria:

• Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication
• The TKA occurred at least 12 weeks prior to enrollment
• Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

Exclusion Criteria:

• Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Journey II BCS Total Knee System; Subjects having TKA with Journey II BCS Total Knee System	Device: Journey II BCS Total Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision Rate of Total Knee System	Number of revisions	implantation through study completion, approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of adverse events reported per ISO 14155 guidelines	implantation through study completion, approximately 3 years
Health care utilization: Hospitalization	Length of hospital stay for primary (index) surgery	implantation through study completion, approximately 3 years
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
Patient reported outcomes	EQ-5D-3L	implantation through study completion, approximately 3 years
Clinical outcomes	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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2016
• Primary Completion (ACTUAL): January 30, 2018
• Study Completion (ACTUAL): September 24, 2018

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; degenerative arthritis; post-traumatic arthritis; failed osteotomy
• Other Study ID Numbers: 16-4049-08

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.: No