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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1694 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-30

Study Completion Date

2018-09-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Total Knee Arthroplasty

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Journey II BCS Total Knee System

Subjects having TKA with Journey II BCS Total Knee System

Journey II BCS Total Knee System

Intervention Type DEVICE

Interventions

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Journey II BCS Total Knee System

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes