fMRI Feasibility Older Hip Fracture Surgery

Hip Fractures Clinical Trial

Official title:

Functional MRI in Older People Following Hip Fracture Surgery: a Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05081726
• Other study ID #: 19087
• Status: Not yet recruiting
• Start date: July 4, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: May 2022
• Source: University of Nottingham
• Contact: Abiodun Moronke Noah, FRCA
• Phone: 01158231011
• Email: abi.noah[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery

Description:

Postoperative delirium, an acute sate of confusion occurs with higher frequency in older people. Hip fracture surgery is a procedure associated with an increased risk of postoperative delirium.

In the study the feasibility of achieving structure and functional connectivity imaging of the brain, using magnetic resonance imaging, in older people who are recovering from hip fracture surgery will be assessed.

People who have recovered from post operative delirium and people who did not have postoperative delirium will be included.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 6, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:Age

• Age = 65 years

• Cognitively intact

• primary admission for hip fracture surgery

Exclusion Criteria:

• Cognitive impairment

• Less than moderate level of activities of daily living

• History of neurosurgery/significant head trauma

• Acutely unwell/moribund

• Presence of neurological diseases including overt stroke, dementia, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders.

• Postural or movement disorders likely to impede MRI scan

• Contraindications to MRI

• Complex fractures/multiple injuries

Related Conditions & MeSH terms

• Delirium
• Fractures, Bone
• Hip Fractures
• Magnetic Resonance Imaging
• Postoperative Delirium

Intervention

Diagnostic Test:
• Functional MRI
Series of MRI scans of the brain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process	The feasibility of transferring participants to and achieving structural and functional MRI scans. Specifically we will assess the number of participants in whom scans were successfully achieved	From time of consent to day after MRI scan which is up to 5 days
Secondary	Abnormalities of functional connectivity	Identify any differences in functional connectivity between the resolved delirium and the never delirium MRI scans	Up to one month after scans have been achieved
Secondary	Pain assessment.	An assessment of baseline pain levels and then repeat assessments of pain during transfer and the MRI scanning process using the numerical pain rating scale	From immediately prior to transfer to the MRI suite until return to own hospital bed which is approximately 2 hours
Secondary	Actual times taken to achieve scans	An assessment of unforeseen constraints on time taken to scan	Up to 60 minutes
Secondary	Participant feedback	The participant experience will be explored via verbal feedback which will be documented by the accompanying researcher	Two occassions. The first immediately after return from the MRI scan suite. The second will occur the day after scanning. Each will take 5 minutes.