Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS) (JIICR)
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Number of adverse events reported per ISO 14155 guidelines [ Time Frame: 7 years ]
Secondary Outcome Measures :
Length of hospital stay for primary (index) surgery [ Time Frame: 7 years ]
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: 7 years ]
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery [ Time Frame: upon occurence through 7 years of study duration ]
Number of rehabilitation sessions [ Time Frame: 7 years ]
Duration of rehabilitation sessions in weeks [ Time Frame: 7 years ]
Number and type of outpatient visits [ Time Frame: 7 years ]
Number of re-operations [ Time Frame: 7 years ]
Quality of Life as measured by EQ-5D-3L score [ 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.
Patient Pain Level as measured by Knee Society Score (KSS) [ 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.
Number of days before return to work [ Time Frame: 7 years ]
Number of technical difficulties encountered with the device [ Time Frame: 7 years ]
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis; failed osteotomies or unicompartmental replacement. This system is designed for use in patients having primary total knee replacement surgery, where the cruciate ligaments and the collateral ligaments remain intact.
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