NCT06893406

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

March 18, 2025

Last Update Submit

October 30, 2025

Conditions

Keywords

Hip fractureCervical myelopathy

Outcome Measures

Primary Outcomes (2)

  • Detection of cervical myelopathy on history and physical exam

    The number of hip fracture participants whose history and physical exam positively demonstrate signs or symptoms of cervical myelopathy will be compared to the number of hip fracture participants whose history and physical exam do not demonstrate signs or symptoms of cervical myelopathy.

    Once, at time of enrollment

  • Diagnosis of cervical myelopathy on cervical MRI

    Hip fracture participants whose history and physical exam positively demonstrate signs or symptoms of cervical myelopathy will be referred for a cervical MRI, to occur prior to hospital discharge. The number of participants whose cervical MRI confirms this diagnosis will be compared to the number of participants for whom cervical MRI does not confirm this diagnosis.

    Once, prior to hospital discharge

Study Arms (1)

Evaluation for Cervical Myelopathy

EXPERIMENTAL

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.

Diagnostic Test: Cervical MRIOther: History & Physical Exam

Interventions

Cervical MRIDIAGNOSTIC_TEST

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

Evaluation for Cervical Myelopathy

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

Evaluation for Cervical Myelopathy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University North Hospital

Fishers, Indiana, 46032, United States

RECRUITING

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26562581BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Health Records, PersonalRestraint, Physical

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Medical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesBehavior ControlTherapeuticsImmobilization

Central Study Contacts

Zachary J Gunderson, MD

CONTACT

Rowan Flynn, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: All hip fracture patients that provide consent for participation will undergo a history and physical examination to specifically evaluate for potential cervical myelopathy. If the history and physical exam detect signs or symptoms of cervical myelopathy, a cervical MRI will be scheduled to confirm the diagnosis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Neurological Surgery

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

May 1, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations