Total knee arthroplasty with Journey II CR Total Knee System
DeviceTKA with Journey II CR Total Knee System
NCT Number: NCT03885531
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
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Observational
Orthopaedic Specialists of Scottsdale, Scottsdale, Arizona, United States
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TKA with Journey II CR Total Knee System
Time frame: 7 years
Time frame: 7 years
Time frame: 7 years
Time frame: upon occurence through 7 years of study duration
Time frame: 7 years
Time frame: 7 years
Time frame: 7 years
Time frame: 7 years
Time frame: 7 years
The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: 7 years
Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities.
Time frame: 7 years
Time frame: 7 years
Smith & Nephew, Inc.
Industry
Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study
Acronym: JIICR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.