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Completed

NCT Number: NCT03903731

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty with Journey II BCS Total Knee System

Device

Journey II BCS Total Knee System

Primary outcomes

  1. Revision of one or more study device components

    Time frame: Implantation through study completion, approximately 8 years

    We are measuring the number of revision cases

Secondary outcomes

  1. Health care utilization: Rehabilitation

    Time frame: Implantation through study completion, approximately 8 years

    Number of sessions and duration of rehabilitation in weeks

  2. Return to Work

    Time frame: Implantation through study completion, approximately 8 years

    Changes in employment status will be recorded with the date on which the change occurred and the change status.

  3. Knee Society Score (KSS)

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  4. Visual Analogue Scale (VAS)

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  5. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  6. Total Knee Assessment Score

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  7. Oxford Knee Assessment (OKS)

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  8. Knee Injury and Osteoarthritic Outcome Score (KOOS)

    Time frame: Baseline through last study visit, approximately 8 years

    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.

  9. Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)

    Time frame: Baseline through last study visit, approximately 8 years

    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).

  10. SF-12 Version 1

    Time frame: Baseline through last study visit, approximately 8 years

    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)

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Acronym: JIIPROMS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.