Clinical trial NCT03798847: Safety and Performance of Journey II XR Total Knee System
Official title: Safety and Performance of Journey II XR Total Knee System. A Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Journey II XR Total Knee System
Keywords: Journey II XR Total Knee System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication

Brief summary: The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.


Eligibility criteria: Inclusion Criteria:

* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication;
* The TKA occurred at least 12 weeks prior to enrollment.

Exclusion Criteria:

- None

Primary outcomes:
measure: Revision of one or more study device components
timeFrame: 12 weeks follow up
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 weeks follow up
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: Quality of Life: EQ-5D-3L
timeFrame: Implantation through study completion, approximately 3 years
measure: Quality of Life: KSS
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: Phoenix
country: United States
facility: Orthopedic Institute of the West
state: Arizona
city: Aurora
country: United States
facility: Rush Copley Orthopaedics
state: Illinois
city: Port Huron
country: United States
facility: Jerry Orthopaedic Institute
state: Michigan
city: Reno
country: United States
facility: Reno Orthopedic Clinic
state: Nevada
city: Somerset
country: United States
facility: Orthopaedic Center of New Jersey
state: New Jersey
city: New York
country: United States
facility: Hospital for Joint Diseases Orthopaedics Institute
state: New York
city: Oregon City
country: United States
facility: Regenerative Orthopedic Center (ROC)
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: San Antonio
country: United States
facility: San Antonio Orthopaedic Specialists
state: Texas
city: Alexandria
country: United States
facility: Anderson Orthopaedic Clinic
state: Virginia
city: Huntington
country: United States
facility: Scott Orthopedic Center
state: West Virginia
city: Kenosha
country: United States
facility: Aurora Medical Center
state: Wisconsin
Study officials:
References: