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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
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Rheumatoid Arthritis Traumatic Arthritis Posttraumatic Deformity Varus Deformity Valgus Deformity Osteotomy Arthrodesis Procedure: Vanguard Rocc

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.


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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. Safety and performance of the device by recording all adverse events [ Time Frame: 10 years ]
    assessment of all occured adverse events

  4. Calculation of survivorship using revision of prosthesis as the failure event [ Time Frame: 10 years ]
    survivorship calculation by Kaplan-Meier technology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

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:

  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • Osteoporosis,
  • Metabolic disorders which may impair bone formation,
  • Osteomalacia,
  • Distant foci of infections which may spread to the implant site,
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  • Vascular insufficiency, muscular atrophy, neuromuscular disease,
  • Incomplete or deficient soft tissue surrounding the knee.

Information from the National Library of Medicine

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


Locations
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Belgium
ZNA Jan Palfijn
Merksem, Belgium
Denmark
Sydvestjysk Hospital
Grindsted, Denmark
Hvidovre University Hospital
Hvidovre, Denmark
France
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
United Kingdom
South West London Elective Orthopaedic centre - EPSOM General Hospital
Epsom, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Paola Vivoda Zimmer Biomet

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03664791     History of Changes
Other Study ID Numbers: BMETEU.CR.EU32
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Osteoarthritis, Knee
Congenital Abnormalities
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases