Clinical trial NCT03292003: Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Official title: Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Keywords: rheumatoid arthritis
post-traumatic arthritis
osteoarthritis
degenerative arthritis
failed osteotomy
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 1694
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Revision Rate of Total Knee System
timeFrame: implantation through study completion, approximately 3 years
Secondary outcomes:
measure: Adverse Events
timeFrame: implantation through study completion, approximately 3 years
measure: Health care utilization: Hospitalization
timeFrame: implantation through study completion, approximately 3 years
measure: Health care utilization: Hospitalization
timeFrame: implantation through study completion, approximately 3 years
measure: Health care utilization: Rehabilitation
timeFrame: implantation through study completion, approximately 3 years
measure: Health care utilization: Outpatient visits
timeFrame: implantation through study completion, approximately 3 years
measure: Health Care Utilization: Re-operations
timeFrame: implantation through study completion, approximately 3 years
measure: Patient reported outcomes
timeFrame: implantation through study completion, approximately 3 years
measure: Clinical outcomes
timeFrame: implantation through study completion, approximately 3 years
measure: Return to Work
timeFrame: implantation through study completion, approximately 3 years
measure: Technical Difficulties Encountered During Device Implantation
timeFrame: implantation through study completion, approximately 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Orthopaedics
state: Colorado
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Foundation
state: Florida
city: Indianapolis
country: United States
facility: Methodist Sports Medicine
state: Indiana
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: State College
country: United States
facility: University Orthopaedics Center
state: Pennsylvania
city: Knoxville
country: United States
facility: TN Orthopaedic Foundation for Education and Research
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Orthopaedic Specialists
state: Texas
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Wheeling
country: United States
facility: Marra Knee and Shoulder Center
state: West Virginia
city: Hasselt
country: Belgium
facility: Jesse Ziekenhuis
city: Pellenberg
country: Belgium
facility: UZ Leuven Campus
city: Bern
country: Switzerland
facility: Christen Ortho AG
Study officials:
affiliation: Vice President, Global Clinical Strategy
name: Beate Hanson, MD, PhD
role: STUDY_CHAIR
References: