Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)
- Conditions
- Journey II CR Total Knee System
- Registration Number
- NCT03885531
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 586
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of adverse events reported per ISO 14155 guidelines 7 years
- Secondary Outcome Measures
Name Time Method Length of hospital stay for primary (index) surgery 7 years Number and type of outpatient visits 7 years Number of days before return to work 7 years Number of rehabilitation sessions 7 years Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery 7 years Duration of rehabilitation sessions in weeks 7 years Number of re-operations 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 technical difficulties encountered with the device 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
Trial Locations
- Locations (6)
Orthopaedic Specialists of Scottsdale
🇺🇸Scottsdale, Arizona, United States
Pikeville Medical Center
🇺🇸Pikeville, Kentucky, United States
Reno Orthopedic Institute
🇺🇸Reno, Nevada, United States
New York University
🇺🇸New York, New York, United States
OrthoNeuro
🇺🇸New Albany, Ohio, United States
Tennessee Orthopaedic Clinics
🇺🇸Knoxville, Tennessee, United States
Orthopaedic Specialists of Scottsdale🇺🇸Scottsdale, Arizona, United States