MedPath

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

Phase 2
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
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

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
NameTimeMethod
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
NameTimeMethod
To assess wound healing and safety of the medical devices under investigation.
© Copyright 2025. All Rights Reserved by MedPath