Last updated on September 2017

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


Brief description of study

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

Detailed Study Description

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.

Clinical Study Identifier: NCT03292003

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Christopher O'Grady, MD

Andrews Research and Education Foundation
Gulf Breeze, FL United States
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John Hur, MD

Methodist Sports Medicine
Indianapolis, IN United States
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David Mayman, MD

Hospital for Special Surgery
New York, NY United States
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Paul Sensiba, MD

University Orthopaedics Center
State College, PA United States
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Harold Cates, MD

TN Orthopaedic Foundation for Education and Research
Knoxville, TN United States
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Adam Harris, MD

San Antonio Orthopaedic Specialists
San Antonio, TX United States
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Bill Huang, MD

Providence Regional Medical Center
Everett, WA United States
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Dante Marra, MD

Marra Knee and Shoulder Center
Wheeling, WV United States
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Jan Malcorps, MD

Jesse Ziekenhuis
Hasselt, Belgium
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Hilde Vandenneucker, MD

UZ Leuven Campus
Pellenberg, Belgium
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Bernhard Christen, MD

Christen Ortho AG
Bern, Switzerland
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