Orthopedic OperationsNCT01938417
Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute
An observational study of Orthopedic Operations, run by University of Lausanne Hospitals.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Operations
- What is being tested?
- tobramycin
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients treated with Osteoset® T in our orthopedic surgery department
Who may be able to join
- Adult (> or =18 years old) patients
- Treatment with Osteoset® T
Who cannot join
- Intravenous tobramycin
About this study
This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).
- Conditions
- Orthopedic Operations
- Being tested
- tobramycin
- Keywords
- tobramycin, bone graft substitute, pharmacokinetics, renal failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobramycinDrug
| Study group | Role | What they receive |
|---|---|---|
| adult patients treated with Osteoset® T (tobramycin sulfate) | 10 g or 20 g of Osteoset® T Receives: Drug: tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of systemic tobramycin concentration
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.
Measured: within 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startOct 2006
- Primary completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic OperationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francoise Livio, MD, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938417
- Sponsor's protocol ID
- Tobramycin cast
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Livio F, Wahl P, Csajka C, Gautier E, Buclin T. Tobramycin exposure from active calcium sulfate bone graft substitute. BMC Pharmacol Toxicol. 2014 Mar 4;15:12. doi: 10.1186/2050-6511-15-12.
PubMed 24593819
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute
- ClinicalTrials.gov ID
- NCT01938417
- Acronym / sponsor ID
- Tobramycin cast
- Conditions
- Orthopedic Operations
- Keywords
- tobramycin, bone graft substitute, pharmacokinetics, renal failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients treated with Osteoset® T (tobramycin sulfate) | – | Drug: tobramycin10 g or 20 g of Osteoset® T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients treated with Osteoset® T in our orthopedic surgery department
Key inclusion criteria (2 listed)
- Adult (> or =18 years old) patients
- Treatment with Osteoset® T
Key exclusion criteria (1 listed)
- Intravenous tobramycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tobramycin | Drug | adult patients treated with Osteoset® T (tobramycin sulfate) |
Primary outcome
Measurement of systemic tobramycin concentration
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Derived from this study: PubMed 24593819Livio F, Wahl P, Csajka C, Gautier E, Buclin T. Tobramycin exposure from active calcium sulfate bone graft substitute. BMC Pharmacol Toxicol. 2014 Mar 4;15:12. doi: 10.1186/2050-6511-15-12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Operations, run by University of Lausanne Hospitals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of systemic tobramycin concentration (time frame: within 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.