Cervical Myelopathy in Hip Fracture Patients

NCT ID: NCT06893406

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-03-20

Brief Summary

Recent evidence has demonstrated a high rate of undiagnosed cervical myelopathy in patients presenting with hip fractures from a ground level fall. Identification and treatment of cervical myelopathy can help prevent falls and future fragility fractures. The purpose of this study is to screen ground level fall hip fracture patients for cervical myelopathy using a history, physical exam, and then offer an MRI if indicated.

Detailed Description

Cervical myelopathy is compression of the cervical spinal cord which causes many things, but a common and prominent symptom is poor coordination/balance. This has been shown in multiple high quality studies to increase a patient's risk of falls as well as fragility fractures (such as hip fractures). Often, patients with hip fractures present with multiple falls of unknown origin. Work up from an orthopedic perspective is rare, but our medicine colleagues spend a substantial amount of resources to identify a cause (carotid ultrasound, head CT, EKG, echo, labs, etc.). This is because hip fractures in the elderly come with a 10-30% risk of death at one year. Preventing a fall that causes a hip fracture is very important, and we, as orthopedists, are well positioned to aid in that endeavor. 8 years ago a study was published in a prominent orthopedic journal looking at cervical myelopathy in hip fracture patients. With 28 hip fracture patients, they found an 18% rate of cervical myelopathy. This was diagnosed on history and physical exam. MRIs were offered but not obtained. To date, this is the only study on this subject. This study will be similar but will go a step further and obtain a cervical spine MRI to complete the diagnosis of cervical myelopathy for these patients. This can help get them on the pathway for treatment and future fall prevention.

How it will work:

Once a patient sustains a hip fracture and is admitted to either Methodist hospital, IU North hospital, or Eskenazi hospital, study team will screen the patient for inclusion and exclusion criteria via chart review. If criteria are met, the patient will be seen in the hospital by study team and the patient will be consented for the study. The study team will do a physical exam and take a history from the patient for research purposes, looking for signs/symptoms of cervical myelopathy. If it is determined the patient likely has cervical myelopathy, as standard of care, the patient will be offered an MRI and possibly be referred to a surgeon.

Conditions

Cervical Myelopathy; Hip Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Evaluation for Cervical Myelopathy

Hip fracture patients who agree to participate will undergo a history and physical exam to specifically evaluate for clinical signs or symptoms of cervical myelopathy. If the history and physical exam is positive for such symptoms, a cervical MRI will be scheduled as part of standard care to further evaluate for this diagnosis. If the history and physical exam is negative for such symptoms, further clinical evaluation for this condition will not occur.

Group Type: EXPERIMENTAL

Cervical MRI

Intervention Type: DIAGNOSTIC_TEST

Participants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI.

History & Physical Exam

Intervention Type: OTHER

A history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed.

Interventions

Cervical MRI

Participants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI.

Intervention Type: DIAGNOSTIC_TEST

History & Physical Exam

A history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient admitted to Eskenazi, Methodist, or IU North hospital for a hip fracture (femoral neck, intertrochanteric, subtrochanteric, or pertrochanteric fracture) that was caused by a ground level fall.

Exclusion Criteria

• Neurologic or cognitive disorder explaining the fall (dementia, Parkinson's disease, delirium, etc.)
• Syncopal fall or fall caused by stroke or a heart condition

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jamie Bradbury

Associate Professor of Clinical Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University North Hospital

Fishers, Indiana, United States

Site Status: RECRUITING

Eskenazi Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zachary J Gunderson, MD

Role: CONTACT

zgunders@iu.edu

2193215850

Rowan Flynn, MD

Role: CONTACT

8082641713

Facility Contacts

Zachary Gunderson, MD

Role: primary

zgunders@iu.edu

219-321-5850

Zachary Gunderson, MD

Role: primary

zgunders@iu.edu

219-321-5850

Zachary Gunderson, MD

Role: primary

zgunders@iu.edu

219-321-5850

References

Radcliff KE, Curry EP, Trimba R, Walker JB, Purtill JJ, Austin MS, Parvizi J, Vaccaro AR, Hilibrand AS, Albert TJ. High Incidence of Undiagnosed Cervical Myelopathy in Patients With Hip Fracture Compared With Controls. J Orthop Trauma. 2016 Apr;30(4):189-93. doi: 10.1097/BOT.0000000000000485.

Reference Type: BACKGROUND

PMID: 26562581 (View on PubMed)

Other Identifiers

24990

Identifier Type: -

Identifier Source: org_study_id