A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
Running, not enrolling
Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Post Traumatic Deformity, Complications; Arthroplasty, Deformity of Limb
In brief
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.
Key facts
- Study ID
- NCT01542580
- Run by
- Zimmer Biomet
- People needed
- 255
- Starts
- 2012-03-01
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Illinois Bone and Joint — Morton Grove, Illinois, United States
- Orthopedic Institute of Henderson — Henderson, Nevada, United States
- University of Utah Orthopedic Center — Salt Lake City, Utah, United States
- OrthoVirginia West End Orthopedic Clinic — Richmond, Virginia, United States
- University Hopital Pellenberg — Pellenberg, Belgium
- Aarhus university hospital — Aarhus, Denmark
- Ch Lyon Sud — Lyon, France
- Klinik fur Endoprothetik und gelenkchirurgie — Bad Wildbad, Germany
- IRCCS Istituto Ortopedico Galeazzi — Milan, Italy
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
- University Hospital Mutua de Terrasa — Terrassa, Spain
- Royal Orthopaedic Hospital — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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