Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/12/2012
Date assigned
21/03/2013
Last edited
26/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study on patients who have sustained a fractured hip in order to compare
different doses of antibiotics within the cement at the time of hip surgery. Our goal is to establish if adding a higher dose of antibiotics into the cement will reduce the rate of surgical site infection. We will look at a number of patient characteristic such as age, gender, rates of infection, timing of surgery, and other characteristics. The study's findings should help to improve the well being of patients with a fractured hip in the UK and to enhance the country's research base in orthopaedic infection.

Who can participate?
The study aims to recruit about 850 patients, aged above 18 years old, from the Northumbria NHS Trust (UK) who have sustained a fractured hip.

What does the study involve?
Patients will be randomly allocated to one of two groups. Randomisation, which is like a coin toss, will allocate the antibiotic cement given to the patient. Group 1 will receive low antibiotic dose cement (that is used in normal practice) and group 2 will receive high antibiotic dose cement (that is used in other forms of hip surgery in normal practice). Both groups will then have the same postoperative care and follow up. At the end of the study, we will compare the rates of surgical site infection between the groups. Patients will be given the same clinical care whether they are in group 1 or 2.

What are the possible benefits and risks of participating?
Risks include those normally associated with an operation and will be discussed at the time of the operation. The study may lead to a positive change in treatment for this operation in the NHS. There may be no differences between the two groups.

Where is the study run from?
The study has been set up by the Northumbria NHS Trust (UK).

When is the study starting and how long is it expected to run for?
Recruitment started in July 2008. Participants will be enrolled until the target number of 850 is reached.

Who is funding the study?
A small amount of educational funding has been supplied by Heraeus Medical (UK).

Who is the main contact?
Mr Mike Reed, mike.reed@nhs.net
Mr Andrew Sprowson, apsprowson@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mike Reed

ORCID ID

Contact details

Northumbria Healthcare NHS Foundation Trust
Research and Development
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
mike.reed@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Low vs. high dose antibiotic impregnated cement in the treatment of patients with fractured neck of femur: a two arm assessor blinded randomised controlled trial

Acronym

FHIT

Study hypothesis

It is hypothesised that high dose antibiotic impregnated cement will reduce the rates of surgical site infection in patients undergoing a hip hemiarthroplasty for fractured neck of femur vs. standard of care low dose antibiotic impregnated cement.

The null hypothesis is that there will be reduction in surgical site infection between treatment groups.

Ethics approval

NRES Committee Newcastle & North Tyneside 2 Research Ethics Committee, 16 July 2008, ref: 07/H0901/63

Study design

Twin site two arm assessor blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fracture of neck of femur / Surgical site infection / orthopaedic

Intervention

In this pragmatic trial, patients will undergo emergency hip hemiarthroplasty (cemented) using the standard technique of the anaesthetist and the operating surgeon. In addition, the patient will undergo one of the two peri-operative cements:

Usual best standard: Standard cement used to cement the hip hemiarthroplasty into the femur, which contains 0.5g of gentamicin. No technique modification is needed.

Intervention: Revision cement used to cement the hip hemiarthroplasty into the femur, which contains 1g gentamicin and 1g of clindamycin. No technique modification is needed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Deep surgical site infection as defined by the Health Protection Agency

Secondary outcome measures

1. Superficial surgical site infection as defined by the Health Protection Agency
2. Length of stay
3. Surgeon grade will be documented as consultant orthopaedic surgeon, specialist trainee or core training doctor.
4. Admission to high dependency unit
5. All complications will be recorded

All baseline data will be summarised descriptively by treatment group.

Overall trial start date

01/07/2008

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All trauma orthopaedic patients (age 18 and over) who require a hip hemiarthroplasty for a fractured neck of femur will be included in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

848

Participant exclusion criteria

Patients under 18

Recruitment start date

01/07/2008

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
North Shields
NE29 8NH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust (UK)

Sponsor details

c/o Caroline Potts
Research and Development
North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom
Caroline.Potts@northumbria-healthcare.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.northumbria.nhs.uk

Funders

Funder type

Industry

Funder name

Heraeus Medical GmbH (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24344672

Publication citations

  1. Protocol

    Sprowson AP, Jensen CD, Gupta S, Parsons N, Murty AN, Jones SM, Inman D, Reed MR, The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur: a protocol for a double-blind quasi randomised controlled trial., BMC Musculoskelet Disord, 2013, 14, 356, doi: 10.1186/1471-2474-14-356.

Additional files

Editorial Notes