Evaluation of the systemic bioavailability of gentamicin released from Herafill® Beads G and Garamycin® Schwamm in patients after hip-cup arthroplasty in aseptic revision of hip endoprothesis - A comparative, randomized monocentric study
- Conditions
- ASEPTICREVISIONOFHIPENDOPROTHESIS
- Registration Number
- DRKS00023902
- Lead Sponsor
- Heraeus Medical GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To assess wound healing and safety of the medical devices under investigation.