fMRI Feasibility Older Hip Fracture Surgery

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; Hip Fractures; Magnetic Resonance Imaging
• Intervention / Treatment: Diagnostic test: Functional MRI

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Abiodun Moronke Noah, FRCA; Phone Number: 01158231011; Email: abi.noah@nottingham.ac.uk
• Study Contact Backup: Name: Iain K Moppett, DM; Phone Number: 01158230959; Email: iain.moppett@nottingham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Older people recovering from hip fracture surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Never had delirium; Older people recovering from hip fracture surgery who did not have postoperative delirium	Diagnostic test: Functional MRI; Series of MRI scans of the brain
Recovered delirium; Older people recovering from hip fracture surgery who experienced delirium which has resolved	Diagnostic test: Functional MRI; Series of MRI scans of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Actual times taken to achieve scans	An assessment of unforeseen constraints on time taken to scan	Up to 60 minutes
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.

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Rob Dineen, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Anticipated): July 4, 2022
• Primary Completion (Anticipated): September 2, 2022
• Study Completion (Anticipated): December 6, 2022

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Functional MRI; postoperative delirium; older people
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 19087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Incidental findings in participants who give consent for sharing of these with their physician, will be communicated to the general practitioner for further action if required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No