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Clinical Trials in Austria / NCT04076202
Active, not recruiting Not applicable

Clinical Evaluation of Vanguard DD RP

NCT04076202 · tracked via the Priya Life Science Austria tracker
Phase
Not applicable
Started
2013-07-11
Last updated
2024-05-17

Condition(s) studied

Knee OsteoarthritisPost-traumatic OsteoarthritisRheumatoid Arthritis

Investigational drug(s) / intervention(s)

Cementless Vanguard DD RP

Cementless Vanguard DD RP: Patients treated with the Cementless Vanguard DD RP knee implant

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 roentgenogram, * vascular insufficiency, muscular atrophy, neuromuscular disease, * incomplete or deficient soft tissue surrounding the knee

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kepler Universitäts Klinikum Linz Austria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04076202 on ClinicalTrials.gov ↗ ← All trials in Austria