Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | Any |
Updated: | 3/30/2019 |
Start Date: | December 30, 2016 |
End Date: | September 24, 2018 |
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
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.
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.
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
We found this trial at
10
sites
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Gulf Breeze, Florida 32561
Principal Investigator: Christopher O'Grady, MD
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Knoxville, Tennessee 37923
Principal Investigator: Harold Cates, MD
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535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Principal Investigator: David Mayman, MD
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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San Antonio, Texas 78229
Principal Investigator: Adam Harris, MD
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3000 Fairway Drive
State College, Pennsylvania 16602
State College, Pennsylvania 16602
Principal Investigator: Paul Sensiba, MD
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2000 Eoff Street
Wheeling, West Virginia 26003
Wheeling, West Virginia 26003
Principal Investigator: Dante Marra, MD
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