Fractured Hip Infection Trial: FHIT- low vs. high dose antibiotic impregnated cement in the treatment of patients with fractured neck of femur
| ISRCTN | ISRCTN25633145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25633145 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/12/2012
- Registration date
- 21/03/2013
- Last edited
- 18/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Northumbria Healthcare NHS Foundation Trust
Research and Development
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
| mike.reed@nhs.net |
Study information
| Study design | Twin site two arm assessor blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | FHIT |
| Study objectives | 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(s) | NRES Committee Newcastle & North Tyneside 2 Research Ethics Committee, 16 July 2008, ref: 07/H0901/63 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2008 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 848 |
| Key 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 |
| Key exclusion criteria | Patients under 18 |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE29 8NH
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Caroline Potts
Research and Development
North Tyneside General Hospital
North Shields
NE29 8NH
England
United Kingdom
| Caroline.Potts@northumbria-healthcare.nhs.uk | |
| Website | http://www.northumbria.nhs.uk |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/12/2013 | Yes | No | |
| Results article | results | 01/11/2016 | Yes | No |
Editorial Notes
18/10/2018: Publication reference added.
