Vanguard Rocc Post Market Surveillance

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03664791
• Other study ID #: BMETEU.CR.EU32
• Status: Active, not recruiting
• Start date: October 23, 2009
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthrodesis
• Congenital Abnormalities
• Osteoarthritis, Knee
• Osteotomy
• Posttraumatic Deformity
• Rheumatoid Arthritis
• Traumatic Arthritis
• Valgus Deformity
• Varus Deformity

Intervention

Procedure:
• Vanguard Rocc
Patient operated with the Vanguard Rocc knee prosthesis

Locations

Country	Name	City	State
Belgium	ZNA Jan Palfijn	Merksem
Denmark	Sydvestjysk Hospital	Grindsted
Denmark	Hvidovre University Hospital	Hvidovre
France	Clinique Pasteur	Guilherand-Granges
France	Clinique des Fontaines	Melun
France	Clinique d'Argonay	Pringy
France	Clinique d'Argonayy	Pringy
France	Clinique du Renaison	Roanne
United Kingdom	South West London Elective Orthopaedic centre - EPSOM General Hospital	Epsom

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	10 years
Secondary	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
Secondary	Safety and performance of the device by recording all adverse events	assessment of all occured adverse events	10 years
Secondary	Calculation of survivorship using revision of prosthesis as the failure event	survivorship calculation by Kaplan-Meier technology	10 years