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| Name | Class |
|---|---|
| Nor Consult | UNKNOWN |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty with Journey II CR Total Knee System | Device | TKA with Journey II CR Total Knee System |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events reported per ISO 14155 guidelines | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay for primary (index) surgery | 7 years | |
| Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery | 7 years | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Navarrete | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialists of Scottsdale | Scottsdale | Arizona | 85255 | United States | ||
| Pikeville Medical Center |
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| 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 |
| Number of re-operations | 7 years |
| Quality of Life as measured by EQ-5D-3L score | 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. | 7 years |
| Patient Pain Level as measured by Knee Society Score (KSS) | 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. | 7 years |
| Number of days before return to work | 7 years |
| Number of technical difficulties encountered with the device | 7 years |
| Pikeville |
| Kentucky |
| 41501 |
| United States |
| Reno Orthopedic Institute | Reno | Nevada | 89503 | United States |
| New York University | New York | New York | 10003 | United States |
| OrthoNeuro | New Albany | Ohio | 43054 | United States |
| Tennessee Orthopaedic Clinics | Knoxville | Tennessee | 37922 | United States |
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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