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Completed

NCT Number: NCT03885531

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Specialists of Scottsdale, Scottsdale, Arizona, United States

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Who can participate

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

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

Treatment and study plan

Total knee arthroplasty with Journey II CR Total Knee System

Device

TKA with Journey II CR Total Knee System

Primary outcomes

  1. Number of adverse events reported per ISO 14155 guidelines

    Time frame: 7 years

Secondary outcomes

  1. Length of hospital stay for primary (index) surgery

    Time frame: 7 years

  2. Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery

    Time frame: 7 years

  3. Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery

    Time frame: upon occurence through 7 years of study duration

  4. Number of rehabilitation sessions

    Time frame: 7 years

  5. Duration of rehabilitation sessions in weeks

    Time frame: 7 years

  6. Number and type of outpatient visits

    Time frame: 7 years

  7. Number of re-operations

    Time frame: 7 years

  8. Quality of Life as measured by EQ-5D-3L score

    Time frame: 7 years

    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.

  9. Patient Pain Level as measured by Knee Society Score (KSS)

    Time frame: 7 years

    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.

  10. Number of days before return to work

    Time frame: 7 years

  11. Number of technical difficulties encountered with the device

    Time frame: 7 years

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Collaborators

  • Nor Consult

Registry information

Official study title

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

Acronym: JIICR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2019
Registry last updated
Jan 3, 2024

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.