ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Infection

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]

Treatment: Drugs

Intervention code [2]

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]

HPLC of cancellous bone and subcutaneous fat analysing cefazolin concentrations

Timepoint [1]

Skin incision - Fat
Humeral head removal - Bone + fat
Glenoid reaming - Bone + fat
Prior to closure - Fat

Secondary outcome [1]

Rate of post-operation infection reported via health staff to ensure safety

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

St Andrew's - Ipswich Private Hospital - Ipswich

Recruitment postcode(s) [1]

4305 - Ipswich

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Matthew Belford

Address [1]

2 Gray St, Ipswich, QLD, 4305

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

St Andrew's Hospital

Address [2]

Roderick St, IPSWICH QLD 4305

Country [2]

Australia

Funding source category [3]

Self funded/Unfunded

Name [3]

Dr Mark Shillington

Address [3]

2 Gray St, IPSWICH QLD 4305

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Human Research Ethics Committee - Greenslopes Private Hospital

Ethics committee address [1]

Greenslopes Private Hospital, Newdegate St, Greenslopes QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/03/2018

Approval date [1]

Ethics approval number [1]

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

Mr Matthew Belford

Address

Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310

Country

Australia

Phone

+61 07 3819 0044

Fax

+61 07 3819 0088

admin@drshillington.com.au

Contact person for public queries

Name

Matthew Belford

Address

Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310

Country

Australia

Phone

+61 07 3819 0044

Fax

+61 07 3819 0088

admin@drshillington.com.au

Contact person for scientific queries

Name

Matthew Belford

Address

Westside Orthopaedics & Sports Medicine, 2 Gray St, Ipswich, QLD, 4310

Country

Australia

Phone

+61 07 3819 0044

Fax

+61 07 3819 0088

admin@drshillington.com.au

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.

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