Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000001998
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
4/01/2011
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regional delivery of prophylactic antibiotics in total knee arthroplasty via an intraosseous route
A tissue penetration study
Scientific title
Total Knee Arthroplasty patients given intraosseous or systemic prophylactic antibiotics and tissue concentrations measured
Secondary ID [1] 253290 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infected total knee arthroplasty 256472 0
Condition category
Condition code
Surgery 256640 256640 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediately following tourniquet inflation Group 1 would then receive a single 1g dose of cefazolin via an intraosseous cannula into the proximal tibia. The cefazolin would be administered in 200ml of saline solution.
Intervention code [1] 255756 0
Treatment: Drugs
Comparator / control treatment
Group 2 will receive a single 1g dose of cefazolin via the systemic route, ten minutes prior to tourniquet inflation.
Control group
Active

Outcomes
Primary outcome [1] 257531 0
Primary outcome is Cephazolin concentration in tissue. Seven samples will be taken from each patient, 4 fat samples and 3 bone samples. Each sample will be approximately the size of a pinhead. Bone samples will be taken from the femur only to ensure no direct contamination from the site of injection (tibia). Due to the small size of the samples it is anticipated that there will be no detrimental effect on the patient whatsoever. Samples will be stored at Middlemore hospital lab at -90 degrees Celsius, before being sent to Christchurch for analysis using a technique called high performance liquid chromatography (HPLC), which will determine the concentration of Cefazolin in each sample.
Timepoint [1] 257531 0
15 minute intervals post administration
Secondary outcome [1] 262763 0
Nil
Timepoint [1] 262763 0
Nil

Eligibility
Key inclusion criteria
Total Knee Replacement patients
Osteoarthritis
Body Mass Index (BMI)<30
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection
Impaired renal function
Allergiy to antibiotic

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes opened at time of enrollment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 2385 0
New Zealand
State/province [1] 2385 0

Funding & Sponsors
Funding source category [1] 256243 0
Hospital
Name [1] 256243 0
CCRep
Country [1] 256243 0
New Zealand
Primary sponsor type
Hospital
Name
Middlmore Hospital
Address
Middlemore Hospital
PO Box 93311
Otahuhu
Auckland
Country
New Zealand
Secondary sponsor category [1] 251573 0
None
Name [1] 251573 0
Address [1] 251573 0
Country [1] 251573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258334 0
Northern X Ethics Commitee
Ethics committee address [1] 258334 0
Ministry of Health
650 Great South Road
Private Bag 92522
Wellesley Street
Auckland
Ethics committee country [1] 258334 0
New Zealand
Date submitted for ethics approval [1] 258334 0
05/01/2009
Approval date [1] 258334 0
01/03/2009
Ethics approval number [1] 258334 0
NTX/10/02/002

Summary
Brief summary
The aim of this study is to assess the feasibility of the intraosseous route in providing higher local tissue concentrations of prophylactic antibiotics in knee replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30661 0
Address 30661 0
Country 30661 0
Phone 30661 0
Fax 30661 0
Email 30661 0
Contact person for public queries
Name 13908 0
Simon Young
Address 13908 0
Middlemore Hospital
PO Box 93311
Otahuhu
Auckland
Country 13908 0
New Zealand
Phone 13908 0
+6421616183
Fax 13908 0
Email 13908 0
simonwyoung@gmail.com
Contact person for scientific queries
Name 4836 0
Simon Young
Address 4836 0
Middlemore Hospital
PO Box 93311
Otahuhu
Auckland
Country 4836 0
New Zealand
Phone 4836 0
+6421616183
Fax 4836 0
Email 4836 0
simonwyoung@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.