Clinical Evaluation of Vanguard DD RP (NCT04076202) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Evaluation of Vanguard DD RP
Austria113 participantsStarted 2013-07-11
Plain-language summary
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
Who can participate
Age range18 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 scheduled to undergo primary total knee replacement:
* with painful and disabled knee joint resulting from any of the following diagnoses:
* Osteoarthritis,
* Traumatic arthritis,
* Rheumatoid arthritis with one or more compartments involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy or arthrodesis.
* 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:
* Infection
* Osteomyelitis
* Previous partial or total prosthetic knee replacement on the operative side
* Skeletal immaturity of the patient
* Sepsis
* Patients who are less than 18 years of age
* 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 roentgeno…