Vanguard Rocc Post Market Surveillance

Zimmer Biomet

Status: Active, not recruiting

Conditions: Valgus Deformity; Traumatic Arthritis; Posttraumatic Deformity; Arthrodesis; Osteotomy; Osteoarthritis, Knee; Varus Deformity; Rheumatoid Arthritis

Treatments: Procedure: Vanguard Rocc

Study type: Observational

Funder types: Industry

Identifiers

NCT03664791

BMETEU.CR.EU32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 1 patient group

Vanguard Rocc knee implant

Description:

Patient in need for a total knee arthroplasty and who met the inclusion/ exclusion criteria and received the Vanguard Rocc implant

Treatment:

Procedure: Vanguard Rocc