Prospective Multi-Center Study on Vanguard With E1 Bearing (NCT02088372) | Clinical Trial Compass
TerminatedNot Applicable
Prospective Multi-Center Study on Vanguard With E1 Bearing
Stopped: All 4 sites were terminated due to low follow-up of patients and low interest in the study
South Korea200 participantsStarted 2012-11
Plain-language summary
Evaluate Clinical Performance of Vanguard Knee with E1 Bearing in Korean Patient Population
Who can participate
Age range20 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients will be included in this study if they received Vanguard knee with E1 Bearing per the approved indications for use for Vanguard Knee. Specifically
* Painful and disabled knee joint resulting from osteoarthritis or traumatic arthritis where one or more compartments are involved
* Correction of varus, valgus, or posttraumatic deformity
* Correction or revision of unsuccessful osteotomy
Exclusion Criteria:
Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Vanguardâ„¢ Knee and the E1â„¢ Tibial Bearing. These indications are stated below:
Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement
Relative contraindications include:
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis
* Metabolic disorders which may impair bone formation
* 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