Clinical trial NCT03664791: Vanguard Rocc Post Market Surveillance
Official title: Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Rheumatoid Arthritis
Traumatic Arthritis
Posttraumatic Deformity
Varus Deformity
Valgus Deformity
Osteotomy
Arthrodesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: Functional outcomes assessment
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic outcomes assessment
timeFrame: 10 years
measure: Assesment of health-related quality of life using the EQ-5D score
timeFrame: 10 years
measure: Safety and performance of the device by recording all adverse events
timeFrame: 10 years
measure: Calculation of survivorship using revision of prosthesis as the failure event
timeFrame: 10 years
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Grindsted
country: Denmark
facility: Sydvestjysk Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Guilherand-Granges
country: France
facility: Clinique Pasteur
city: Melun
country: France
facility: Clinique des Fontaines
city: Pringy
country: France
facility: Clinique d'Argonayy
city: Pringy
country: France
facility: Clinique d'Argonay
city: Roanne
country: France
facility: Clinique du Renaison
city: Epsom
country: United Kingdom
facility: South West London Elective Orthopaedic centre - EPSOM General Hospital
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References: