Evaluation of the Vanguard 360 revision knee system
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
This study is testing a new knee replacement system to see if it helps people with knee problems from arthritis feel less pain and move better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 255 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 12 sites (Morton Grove, Illinois and 11 other locations) |
| Trial ID | NCT01542580 on ClinicalTrials.gov |
What this trial studies
This investigation assesses the performance of the Vanguard 360 revision knee system, focusing on its ability to restore mechanical alignment and improve clinical outcomes for patients with knee joint issues due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis. The study will measure pain relief, functional improvement, range of motion, and patient satisfaction before and after surgery. Additionally, it will evaluate safety through radiographic investigations and track the incidence of complications and revision rates. Standard surgical techniques will be employed, ensuring that no experimental methods are used.
Who should consider this trial
Good fit: Ideal candidates include adults with painful and disabled knee joints due to various forms of arthritis or previous joint replacement failures.
Not a fit: Patients with infections, sepsis, or significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing knee revision surgery, enhancing their quality of life.
How similar studies have performed: Previous studies on knee revision systems have shown promising results, indicating that this approach is built on established methodologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Morton Grove, Illinois and 11 other locations
- Illinois Bone and Joint — Morton Grove, Illinois, United States (Active_not_recruiting)
- Orthopedic Institute of Henderson — Henderson, Nevada, United States (Terminated)
- University of Utah Orthopedic Center — Salt Lake City, Utah, United States (Completed)
- OrthoVirginia West End Orthopedic Clinic — Richmond, Virginia, United States (Active_not_recruiting)
- University Hopital Pellenberg — Pellenberg, Belgium (Enrolling_by_invitation)
- Aarhus university hospital — Aarhus, Denmark (Suspended)
- Ch Lyon Sud — Lyon, France (Terminated)
- Klinik fur Endoprothetik und gelenkchirurgie — Bad Wildbad, Germany (Terminated)
- IRCCS Istituto Ortopedico Galeazzi — Milano, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
- University Hospital Mutua de Terrasa — Terrassa, Spain (Active_not_recruiting)
- Royal Orthopaedic Hospital — Birmingham, United Kingdom (Completed)
Study contacts
- Study coordinator: Andrea Singer
- Email: andrea.singer@zimmerbiomet.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.