A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Launched by ZIMMER BIOMET · Feb 27, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a new knee replacement system called the Vanguard 360, designed for patients with painful and disabled knee joints due to conditions like osteoarthritis or rheumatoid arthritis. The goal is to see how well this knee system can help restore proper alignment and improve patients' overall outcomes after surgery. The trial is currently looking for participants aged 18 and older, with no upper age limit, who have knee problems that may benefit from this type of surgery. Participants should be able to attend follow-up visits and provide written consent to join the study.

If you decide to participate, you can expect to undergo the Vanguard 360 knee replacement procedure and will be monitored over time to assess your recovery and the effectiveness of the implant. However, there are certain criteria that could prevent someone from joining, such as existing infections or other serious health issues. Overall, this trial aims to improve knee replacement options for those struggling with painful knee conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• • Correction of varus, valgus or post-traumatic deformity
• • Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
• • Ability and willingness of the patient to attend follow-up visit.
• • Willing to give written informed consent
• • Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.
• Exclusion Criteria:
• • infection
• • sepsis
• • osteomyelitis
• Relative Contraindications:
• • An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
• • Osteoporosis
• • Metabolic disorders which may impair brain function
• • 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
• • Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.