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OpenTrials
Completed

NCT Number: NCT03798847

Safety and Performance of Journey II XR Total Knee System

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

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Key information

Conditions

Journey II XR Total Knee System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Institute of the West, Phoenix, Arizona, United States

Loading trial locations.

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 XR TKS for approved indication;
  • The TKA occurred at least 12 weeks prior to enrollment.

Exclusion criteria

  • None

Treatment and study plan

Journey II XR TKA

Device

Journey II XR Total Knee System

Primary outcomes

  1. Revision of one or more study device components

    Time frame: 12 weeks follow up

    Measure of the number of revision cases

Secondary outcomes

  1. Adverse Events

    Time frame: 12 weeks follow up

    All collected and reported AEs

  2. Health care utilization: Hospitalization

    Time frame: implantation through study completion, approximately 3 years

    Length of hospital stay for primary (index) surgery

  3. Health care utilization: Hospitalization

    Time frame: Implantation through study completion, approximately 3 years

    Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)

  4. Health care utilization: Rehabilitation

    Time frame: Implantation through study completion, approximately 3 years

    number of sessions and duration of rehabilitation in weeks

  5. Health care utilization: Outpatient visits

    Time frame: Implantation through study completion, approximately 3 years

    Number and type of outpatient visits

  6. Health Care Utilization: Re-operations

    Time frame: Implantation through study completion, approximately 3 years

    Number of re-operations and revisions

  7. Quality of Life: EQ-5D-3L

    Time frame: Implantation through study completion, approximately 3 years

    EuroQol Five Dimensions Questionnaire

  8. Quality of Life: KSS

    Time frame: Implantation through study completion, approximately 3 years

    2011 Knee Society Score

  9. Return to Work

    Time frame: Implantation through study completion, approximately 3 years

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

  10. Technical Difficulties Encountered During Device Implantation

    Time frame: Implantation through study completion, approximately 3 years

    Number of technical difficulties encountered with the device

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Acronym: JIIXR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2019
Registry last updated
Jul 14, 2023

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.