Contact information
Type
Scientific
Primary contact
Mr M Ahmad
ORCID ID
Contact details
The James Cook University Hospital
Orthopaedics Department
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
-
mubashshar72@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227149002
Study information
Scientific title
Randomised controlled trial to compare the magnitude and incidence of haemodynamic changes during fixation of extracapsular fractures of the neck of femur using the compression hip screw versus the intramedullary hip screw
Acronym
Study hypothesis
To determine the magnitude and incidence of haemodynamic changes associated with using a compression hip screw and an intramedullary hip screw to fix extra-capsular fractures of neck of femur.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Extra-capsular fractures of neck of femur
Intervention
Prospective, randomised controlled trial with two limbs. It is a single centred study conducted in the Orthopaedic and Anaesthetic departments at James Cook University Hospital. Patients presenting with extracapsular fractures of the neck of the femur will be asked to participate in the study on the basis of predetermined inclusion criteria.
Randomisation: Computer generated random tables will be used. Delivery of randomisation will be in opaque sealed envelopes to be opened at the time of operation in the operating theatre. Time of 'randomisation (opening the envelope) to delivery of treatment (operation)' will be less than 5 minutes. For this purpose, we propose to have two groups of patients. The patients would be assigned to the groups randomly. One group would be treated using a compression hip screw while the other will be treated using an intramedullary hip screw. All patients will have a preoperative assessment to ensure a stable cardiovascular system. Intraoperative monitoring of the cardiovascular system will be continued through out the operation.
For this purpose, we will place a probe into the oesophagus (gullet) after they have been anaesthetised which would allow us to monitor the heart more effectively. This transoesophageal ultrasound doppler probe has been used in numerous previous studies and in fact it is often used to monitor high-risk patients. It has a no known complication from its use if the exclusion criteria that have been outlined later are strictly adhered to, and if anything the patients would actually benefit from the higher level of monitoring they receive during the procedure. An independent observer, blinded to the group allocation of the patients, and competent in trans-oesophageal doppler probe insertion will record the readings from the probe monitoring. This would increase the validity of the study.
We propose to compare the two groups of patients with regard to their cardiovascular status during the operation and specifically during insertion of the implant. Intraoperative trans-oesophageal doppler monitoring will observe any significant changes in the incidence and magnitude of cardiovascular status or function.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Per-operative (during placement of fixation implant): stroke volume, cardiac output, mean arterial blood pressure, change in arterial blood gases at specified intervals during the surgical procedure
2. Recovery: oxygen saturation, blood pressure
3. Postoperative: Hospital stay, pulmonary embolism mortality
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/04/2004
Overall trial end date
30/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
All patients on admission to the trauma ward with an extracapsular fracture of the neck of femur will be given the opportunity to participate in the study. They will be given the patient information sheet and the opportunity to discuss with the research team. They will be given the opportunity to discuss with their friends, family and GP (if they wish so). If they agree to participate they will be placed on the list but not randomised at that stage. The consent to participate in the study will be taken by the researcher.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. Patients unwilling to take part in the study
2. Paediatric cases (unlikely)
3. Patients not suitable for or not wanting general anaesthesia
4. Patients unable to sign the consent form
5. Known history of deep vein thrombosis
6. Previous oesaphageal surgery (as it can make the placement of oesophageal probe technically unpredictable)
7. Oesophageal varices and other oesophageal abnormalities
8. Pregnant women
Recruitment start date
01/04/2004
Recruitment end date
30/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (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