Journey II CR Total Knee System
Conditions
Keywords
Journey II CR Total Knee System
Brief summary
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
Interventions
DEVICETotal knee arthroplasty with Journey II CR Total Knee System
TKA with Journey II CR Total Knee System
Sponsors
Nor Consult
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication; * The TKA occurred at least 12 weeks prior to enrollment
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events reported per ISO 14155 guidelines | 7 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery | 7 years | — |
| Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery | upon occurence through 7 years of study duration | — |
| Number of rehabilitation sessions | 7 years | — |
| Duration of rehabilitation sessions in weeks | 7 years | — |
| Number and type of outpatient visits | 7 years | — |
| Length of hospital stay for primary (index) surgery | 7 years | — |
| Quality of Life as measured by EQ-5D-3L score | 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. |
| Patient Pain Level as measured by Knee Society Score (KSS) | 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. |
| Number of days before return to work | 7 years | — |
| Number of technical difficulties encountered with the device | 7 years | — |
| Number of re-operations | 7 years | — |
Countries
United States
Outcome results
None listed