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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32393360
Enrollment
42
Registered
2005-09-30
Start date
2004-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra-capsular fractures of neck of femur Injury, Occupational Diseases, Poisoning Fracture of femur

Interventions

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 wi

Sponsors

Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026