NCT01542580Active, not recruiting
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 255 (estimated)
- First submitted
- 27 Feb 2012
- Start date
- Mar 2012
- Primary completion date
- Dec 2031
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT01542580
What you commit to
- Study type: Observational
- Planned participants: 255
- From Mar 2012 to the primary completion date, Dec 2031
- 12 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- infection
- An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
- Metabolic disorders which may impair brain function
- Distant foci of infections which may spread to the implant site
- 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.
Other
- sepsis
- osteomyelitis
- Relative Contraindications:
- Osteoporosis
- Osteomalacia
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hopital Pellenberg Coordinator of this site? Confirm its status | Pellenberg | Belgium | Unknown status |
| Klinik fur Endoprothetik und gelenkchirurgie Coordinator of this site? Confirm its status | Bad Wildbad | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| University Hospital Mutua de Terrasa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| CH Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Royal Orthopaedic Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| IRCCS Istituto Ortopedico Galeazzi Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Orthopedic Institute of Henderson Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Illinois Bone and Joint Coordinator of this site? Confirm its status | Morton Grove | United States | Unknown status |
| OrthoVirginia West End Orthopedic Clinic Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Utah Orthopedic Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.