Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000530224p
Ethics application status
Submitted, not yet approved
Date submitted
28/03/2018
Date registered
10/04/2018
Date last updated
30/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intraosseous Administration of Prophylactic Cefazolin in Total Shoulder Arthoplasty
Scientific title
Local Tissue Concentrations Following Intraosseous Administration of Prophylactic Cefazolin in Total Shoulder Arthoplasty
Secondary ID [1] 294465 0
None
Universal Trial Number (UTN)
U1111-1211-4620
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Prosthesis Infection Prevention 307225 0
Condition category
Condition code
Musculoskeletal 306336 306336 0 0
Osteoarthritis
Infection 306337 306337 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraosseous prophylactic cefazolin administration in total shoulder arthroplasty
Once off 2g cefazolin <1min prior to skin incision by intraosseous cannula inserted by surgeon into greater tuberosity of humerus in addition to 600mg of Lincamycin administered IV 60-30min prior to skin incision by anaesthetist
Intervention code [1] 300758 0
Treatment: Drugs
Intervention code [2] 300824 0
Prevention
Comparator / control treatment
Intravenous prophylactic cefazolin administration in total shoulder arthroplasty
Once off 2g Cefazolin 60-30mins prior to skin incision by anaesthetist in addition to 600mg of Lincamycin administered at the same time
Control group
Active

Outcomes
Primary outcome [1] 305347 0
HPLC of cancellous bone and subcutaneous fat analysing cefazolin concentrations
Timepoint [1] 305347 0
Skin incision - Fat
Humeral head removal - Bone + fat
Glenoid reaming - Bone + fat
Prior to closure - Fat
Secondary outcome [1] 344930 0
Rate of post-operation infection reported via health staff to ensure safety
Timepoint [1] 344930 0
Throughout standard post operation follow up daily until discharge then at 2 weeks, 6 months and 1 year post operation in private rooms unless subject is otherwise worried at which point they will be seen

Eligibility
Key inclusion criteria
Patients undergoing total shoulder arthroplasty at St Andrew's Hospital Ipswich by Dr Mark Shillington.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI >35, Allergy to antibiotics used in study, Abnormal liver or renal function, Recent <1 week antibiotic treatment, Previous compartment syndrome

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)
Central randomisation by computer and placed in sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated random allocations
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Priori power analysis to determine number of participants required - Based on previous cefazolin levels in knee tissue after intraosseous administration

Mean cefazolin concentrations of tissue samples will be calculated with confidence intervals and standard deviations

Significance and repeated-measures analysis of variance will be used to compare cefazolin concentrations

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2018
Actual
Date of last participant enrolment
Anticipated
30/01/2020
Actual
Date of last data collection
Anticipated
29/01/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10519 0
St Andrew's - Ipswich Private Hospital - Ipswich
Recruitment postcode(s) [1] 22233 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 299088 0
Self funded/Unfunded
Name [1] 299088 0
Matthew Belford
Country [1] 299088 0
Australia
Funding source category [2] 299147 0
Hospital
Name [2] 299147 0
St Andrew's Hospital
Country [2] 299147 0
Australia
Funding source category [3] 299148 0
Self funded/Unfunded
Name [3] 299148 0
Dr Mark Shillington
Country [3] 299148 0
Australia
Primary sponsor type
Individual
Name
Matthew Belford
Address
Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD 4305
Country
Australia
Secondary sponsor category [1] 298339 0
None
Name [1] 298339 0
Address [1] 298339 0
Country [1] 298339 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300025 0
Human Research Ethics Committee - Greenslopes Private Hospital
Ethics committee address [1] 300025 0
Greenslopes Private Hospital, Newdegate St, Greenslopes QLD 4120
Ethics committee country [1] 300025 0
Australia
Date submitted for ethics approval [1] 300025 0
30/03/2018
Approval date [1] 300025 0
Ethics approval number [1] 300025 0

Summary
Brief summary
Aim: To determine whether intraosseous (IO) administration of prophylactic cefazolin achieves higher tissue concentrations than IV administration in total shoulder arthroplasty.
Relevance: Propionibacterium Acnes has been shown to be responsible for up to 56% of shoulder infections after orthopaedic implant. Recently papers came out revealing that higher cefazolin and vancomycin concentrations were found in tissue after IO administration rather than IV. This was associated with less colony forming units in a murine model and thus theoretically more effective at reducing infection rates. This was also the case in revision TKA where the tourniquet is down for significant periods. As such, we aim to determine whether this is the case in TSA where no tourniquet is used.
Design: Randomised Control Trial
Method: Patients undergoing TSA will be randomly allocated to either IV or IO prophylactic antibiotic administration groups using computer generated random allocations placed in numbered, opaque, sealed envelopes. Patients will be randomised in the pre-operative area to allow appropriate setup in the operative room.
Upon signing consent, the patients will be asked to complete a demographics survey. The data collected from this survey will be filed electronically using numbers for patients, the number each patient is assigned will be filed safely.
Both IV and IO groups will receive 600mg of Lincomycin as per usual TSA prophylaxis. The IV group will receive 1g Cefazolin at this time (60-30mins prior to incision). The IO group will receive 1g Cefazolin as a bolus in 50mL through in intraosseous cannula, placed in the greater tuberosity of the humerus, after draping and before skin incision. The cannula will be removed and skin incision will follow immediately (<1min).
TSA will proceed as usual and cancellous bone and subcutaneous fat samples will be taken at the following four steps. First subcutaneous fat sample immediately after skin incision, then cancellous bone and subcutaneous fat samples at the time of humeral head removal and glenoid reaming, and the final subcutaneous fat sample immediately before closure. It should be noted that 0.5-1cm2 of each sample will be placed into sterile 15mL tubes kept in ice and water within a biochemical container. The bone samples will come from bone that is removed usually during TSA. A total of two bone samples and four fat samples will be taken from each patient. Patients will be monitored and followed up as per normal TSA protocol.
The biochemical container will be kept in -80-90 degrees Celsius to ensure degradation of cefazolin does not occur prior to analysis. The biochemical container will be transported to Griffith University Gold Coast where analysis via high performance liquid chromatography will be used to determine the cefazolin concentrations of the samples. The laboratory staff will only know the number that the samples belong to and no patient information or the group they belong to will be known.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82298 0
Mr Matthew Belford
Address 82298 0
Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310
Country 82298 0
Australia
Phone 82298 0
+61 07 3819 0044
Fax 82298 0
+61 07 3819 0088
Email 82298 0
[email protected]
Contact person for public queries
Name 82299 0
Mr Matthew Belford
Address 82299 0
Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310
Country 82299 0
Australia
Phone 82299 0
+61 07 3819 0044
Fax 82299 0
+61 07 3819 0088
Email 82299 0
[email protected]
Contact person for scientific queries
Name 82300 0
Mr Matthew Belford
Address 82300 0
Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310
Country 82300 0
Australia
Phone 82300 0
+61 07 3819 0044
Fax 82300 0
+61 07 3819 0088
Email 82300 0
[email protected]

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.