A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee (NCT01542580) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
United States, Belgium255 participantsStarted 2012-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.