A Prospective Munti-center Study on VANGUARDâ„¢ PS Total Knee Replacement System (NCT01906177) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Munti-center Study on VANGUARDâ„¢ PS Total Knee Replacement System
South Korea100 participantsStarted 2012-07
Plain-language summary
The primary objectives of this pilot clinical study include:
* Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population
* Evaluate safety of Vanguard PS Total Knee in Korean population
Who can participate
Age range20 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:
* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
* Need to obtain pain relief and improve function
* Ability and willingness of the patient to follow instructions, including control of weight and activity level
* A good nutritional state of the patient, and
* The patient must have reached full skeletal maturity (at least 18 years old).
Exclusion Criteria:
* infection
* sepsis
* osteomyelitis
* 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