Vanguard Rocc Post Market Surveillance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03664791|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee Rheumatoid Arthritis Traumatic Arthritis Posttraumatic Deformity Varus Deformity Valgus Deformity Osteotomy Arthrodesis||Procedure: Vanguard Rocc|
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.
|Study Type :||Observational|
|Actual Enrollment :||450 participants|
|Official Title:||Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes|
|Actual Study Start Date :||October 23, 2009|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Vanguard Rocc knee implant
Patient in need for a total knee arthroplasty and who met the inclusion/ exclusion criteria and received the Vanguard Rocc implant
Procedure: Vanguard Rocc
Patient operated with the Vanguard Rocc knee prosthesis
- Functional outcomes assessment [ Time Frame: 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.
- Radiographic outcomes assessment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 years ]assessment of all occured adverse events
- Calculation of survivorship using revision of prosthesis as the failure event [ Time Frame: 10 years ]survivorship calculation by Kaplan-Meier technology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664791
|ZNA Jan Palfijn|
|Hvidovre University Hospital|
|Clinique des Fontaines|
|Clinique du Renaison|
|South West London Elective Orthopaedic centre - EPSOM General Hospital|
|Epsom, United Kingdom|
|Study Director:||Paola Vivoda||Zimmer Biomet|