Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures (JIIPROMS)

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• New Zealand
  • Hamilton, New Zealand, 3204
    • Anglesea Clinic Orthopaedics
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Department of Orthopaedics, University of Colorado Denver
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Tennessee Orthopaedic Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who received the Journey II BCS Total Knee System

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision of one or more study device components	We are measuring the number of revision cases	Implantation through study completion, approximately 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care utilization: Rehabilitation	Number of sessions and duration of rehabilitation in weeks	Implantation through study completion, approximately 8 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 8 years
Knee Society Score (KSS)	Knee Society Score (KSS), a physician- and self-administered questionnaire consisting of several items to measure the outcomes; in this study, the following KOOS scores ranging from 0 to 100 were analyzed: Symptoms Score, Satisfaction Score, Expectation Score, Walking and Standing Score, Standard Activity Score, Advanced Activity Score, Discretionary Activity Score, and Functional Activities Score. Lower KSS scores indicated worse knee conditions.	Baseline through last study visit, approximately 8 years
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS), a self-administered psychometric response instrument to evaluate subject-reported assessment of pain in each knee. There are multiple ways to present VAS scores; in this study, the numerical score ranged from 0 to 100 was used, with the higher score corresponding to the worse pain.	Baseline through last study visit, approximately 8 years
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index	The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, a self-administered questionnaire consisting of several items (grouped into symptoms, function, daily living, pain, etc) to measure the outcomes using the scores: Total WOMAC score (sum of all scores), WOMAC pain score (range 0 to 20), WOMAC stiffness score (range 0 to 8), and WOMAC physical function score (range of 0 to 68). The higher WOMAC scores corresponded to worse outcomes.	Baseline through last study visit, approximately 8 years
Total Knee Assessment Score	Total Knee Assessment score is a self-administered questionnaire comprising multiple-choice questions regarding subjects' knee-related pain and limitations in ability to work, sports, and other daily living activities. In this study, the numbers and percentages of subjects answering each multiple-choice question were summarized. The higher percentage of subjects giving an answer indicating a higher level of limitations was indicative of worse outcomes.	Baseline through last study visit, approximately 8 years
Oxford Knee Assessment (OKS)	Oxford Knee Assessment (OKS) is a self-administered questionnaire comprising multiple-choice questions aimed to grade subjects' ability to perform daily activities. The overall score is the sum of all items and range from 0 to 48, with a higher score corresponding to better outcomes.	Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score (KOOS)	Knee Injury and Osteoarthritic Outcome Score (KOOS) is a self -administered joint-specific questionnaire comprising questions regarding subject's symptoms, knee stiffness, pain, function and daily living, function and sports and recreational activities, and quality of life; in this study, the following KOOS scores ranging from 0 to 100 (with a score of 0 indicating the worst possible symptoms) were analyzed: Pain Score, Other Symptoms Score, Function in Daily Living Score, Function in Sport and Recreation Score, and Quality of Life Score.	Baseline through last study visit, approximately 8 years
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)	Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr) is a shorter self-administered alternative to KOOS focusing on joint pain, stiffness, and daily living and allowing for faster completion by the subject. In this study, the KOOS Interval Score ranging from 0 to 100 was analyzed (with a score of 0 indicating the worst possible symptoms).	Baseline through last study visit, approximately 8 years
SF-12 Version 1	SF-12 Version 1 is a self-administered multipurpose (not aimed to specific disease group) short form survey with questions selected from the longer SF-36 Health Survey and comprising the following scores: Physical Health Composite Score (range 0 for the worst health to 100 for the best health) and Mental Health Composite Score (range 0 for the worst health to 100 for the best health)	Baseline through last study visit, approximately 8 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Michael R. Dayton, MD, Department of Orthopaedics, University of Colorado Denver; Principal Investigator: David J. Mayman, MD, Hospital for Special Surgery, New York; Principal Investigator: Harold E. Cates, MD, Tennessee Orthopaedic Clinics; Principal Investigator: Hilde Vandenneucker, MD, UZ Leuven; Principal Investigator: Peter Black, MBBCh, Anglesea Clinic Orthopaedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2018
• Primary Completion (ACTUAL): August 8, 2019
• Study Completion (ACTUAL): August 8, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 16-4049-08B

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