Arthrodesis, Osteoarthritis, Knee, Osteotomy, Posttraumatic Deformity, Rheumatoid Arthritis, Traumatic Arthritis, Valgus Deformity, Varus Deformity
Conditions
Brief summary
The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.
Detailed description
The Vanguard rotating platform knee prosthesis (Vanguard ROCC) was launched in March 2009. Therefore there is a need to show the safety and performance of the Vanguard ROCC at long term. A maximum of 10 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators.
Interventions
PROCEDUREVanguard Rocc
Patient operated with the Vanguard Rocc knee prosthesis
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria should be in accordance with Indications for Use for Vanguard-ROCC® Knee System specifically: * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus, or posttraumatic deformity. * Correction or revision of unsuccessful osteotomy, or arthrodesis. Additional inclusion criteria include: * Male or female. * 18 years of age or older * Subjects willing to return for follow-up evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcomes assessment | 10 years | The American Knee Society Clinical Rating System (original method) : Evaluation of the knee joint and functional assessment of patients. Subscale knee assessment: judgement of pain (50 points), stability (25 points)and range of motion (25 points (5 degrees is 1 point). Flexion contracture, extension lag and malalignment should be dealt with as deductions. Maximum Knee score of 100 points. Subscale functional assessment: assessment of patient function for walking distance (50 points)and stair climbing (50points), with deductions for walking aids. Maximum Function score is 100 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic outcomes assessment | 10 years | The Knee Society Total Knee Arthroplasty Roentgenographic Evaluation and Scoring System by Ewald: radiographic assessment for component position, leg and knee alignment, and the prosthesis-bone interface or fixation. To assess the quality of the fixation: the prosthetic interface has a numerical score for components femur, tibia and patella. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths are added for each zone for each of the three components. This total produces a numerical score for each component. Example for interpretation for a seven-zone tibial component: 4 or less and nonprogressive is not significant; 5-9 should be closely followed for progression; and 10 or greater signifies possible or impending failure regardless of symptoms. |
| Assesment of health-related quality of life using the EQ-5D score | 10 years | Euroqol-5 dimensions by the EuroQol Group (EQ-5D) consists of a descriptive system of health-related quality of life by a questionnaire and a thermometer scale. The Questionnaire comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with each 5 levels: no problems (level 1), slight problems (level 2), moderate problems, (level 3) severe problems (level 4) and extreme problems (level 5). The digits for the five dimensions can be combined into a 5-digit number and may be converted to a score (maximum is 1), defined by the health state classification. The Thermometer generates a self rating of current health-related quality of life and has end points of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. It should be used with the 5-digit health state classification to build a composite picture of the respondent's health status. |
| Safety and performance of the device by recording all adverse events | 10 years | assessment of all occured adverse events |
| Calculation of survivorship using revision of prosthesis as the failure event | 10 years | survivorship calculation by Kaplan-Meier technology |
Countries
Belgium, Denmark, France, United Kingdom
Outcome results
None listed