Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.