Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01938417

Enrollment

Registered

2013-09-10

Start date

2006-10-31

Completion date

Unknown

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Operations

Keywords

tobramycin, bone graft substitute, pharmacokinetics, renal failure

Brief summary

This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).

Interventions

DRUGtobramycin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult (\> or =18 years old) patients * Treatment with Osteoset® T

Exclusion criteria

* Intravenous tobramycin

Design outcomes

Primary

Measure	Time frame	Description
Measurement of systemic tobramycin concentration	within 10 days after surgery	Develop a population pharmacokinetic model for tobramycin in patients treated with an active calcium sulfate bone substitute and to predict tobramycin systemic exposure under various dose and renal function levels.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026