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Completed

NCT Number: NCT03292003

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

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

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Key information

Conditions

Total Knee Arthroplasty Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Jesse Ziekenhuis, Hasselt, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Journey II BCS Total Knee System

Device

Primary outcomes

  1. Revision Rate of Total Knee System

    Time frame: implantation through study completion, approximately 3 years

    Number of revisions

Secondary outcomes

  1. Adverse Events

    Time frame: implantation through study completion, approximately 3 years

    Number of adverse events reported per ISO 14155 guidelines

  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. Patient reported outcomes

    Time frame: implantation through study completion, approximately 3 years

    EQ-5D-3L

  8. Clinical outcomes

    Time frame: implantation through study completion, approximately 3 years

    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 BCS Total Knee System. A Retrospective, Multicenter Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Mar 28, 2019

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.

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