ASEPTICREVISIONOFHIPENDOPROTHESIS
Conditions
Interventions
Group 1: Herafill® Beads G
Group 2: Garamycin® Schwamm
Sponsors
Heraeus Medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years 2. Patients with an implanted hip prosthesis which needs surgical revision of aseptic nature. 3. Informed consent given in written form
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Participation in another clinical trial at same time or within the preceding 3 months 2. Any history of hypersensitivity to the active and inactive ingredients of Herafill® Beads G or of Garamycin® Schwamm, or hypersensitivity to any ingredient of the artificial hip cup 3. Concomitant systemic (oral or parenteral) administration of the active ingredient of both medical devices. 4. Congenital dislocation of the hip 5. Active infection of the hip 6. Neoplasms 7. Active rheumatoid arthritis 8. Any concomitant disease which precludes surgical revision of hip endoprosthesis 9. Patients with renal impairments determined by at least one of the following laboratory parameters outside of the normal range: - serum creatinine - serum urea 10. Inner ear damage 11. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study 12. Unreliability or lack of cooperation 13. Lack of a possibility to attend the examinations required by the clinical investigation plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine and compare the pharmacokinetics of gentamicin from Herafill® Beads G and Garamycin® Schwamm by measuring gentamicin concentrations in blood serum, urine and wound secretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess wound healing and safety of the medical devices under investigation. | — |
Countries
Czechia
Contacts
Public ContactDavid Jahoda
1st Orthopaedic Clinic in Motol Teaching Hospital, 1st Medical Faculty, Charles University in Prague
Outcome results
None listed