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This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
Full description
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxford Knee Score, and evaluation of aseptic loosening after 2 years follow up. Patient benefit will be evaluated by means of Knee injury and Osteoarthritis Outcome Score (KOOS) and EQ-5D patient questionnaire. The target enrollment is 113 patients in 1 clinical site in Linz, Austria.
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Inclusion criteria
Patients scheduled to undergo primary total knee replacement:
Need to obtain pain relief and improve function.
Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
A good nutritional state of the patient.
Full skeletal maturity of the patient, patients who are at least 18 years of age.
Patients of either sex.
Consent form read, understood, and signed by patient.
Exclusion criteria
Absolute contraindications include the following diagnoses:
Relative contraindications include:
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113 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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