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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard Rocc | Procedure | Patient operated with the Vanguard Rocc knee prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcomes assessment | 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic outcomes assessment | 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. |
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Inclusion Criteria:
Inclusion criteria should be in accordance with Indications for Use for Vanguard-ROCC® Knee
System specifically:
Additional inclusion criteria include:
Exclusion Criteria:
Exclusion criteria should be in accordance with Absolute and Relative Contraindications for Use for Vanguard-ROCC Knee system: Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
Relative contraindications include:
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Patients in need of a total knee arthroplasty which receive the Vanguard Rocc knee device and who meet all of the inclusion and none of the exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Jan Palfijn | Merksem | Belgium | ||||
| Sydvestjysk Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2024 | |
| Reset | Jan 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2024 | Jan 10, 2025 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001172 | Arthritis, Rheumatoid |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 10 years |
| Assesment of health-related quality of life using the EQ-5D score | 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. | 10 years |
| Safety and performance of the device by recording all adverse events | assessment of all occured adverse events | 10 years |
| Calculation of survivorship using revision of prosthesis as the failure event | survivorship calculation by Kaplan-Meier technology | 10 years |
| Grindsted |
| Denmark |
| Hvidovre University Hospital | Hvidovre | Denmark |
| Clinique Pasteur | Guilherand-Granges | France |
| Clinique des Fontaines | Melun | France |
| Clinique d'Argonayy | Pringy | France |
| Clinique d'Argonay | Pringy | France |
| Clinique du Renaison | Roanne | France |
| South West London Elective Orthopaedic centre - EPSOM General Hospital | Epsom | United Kingdom |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |