- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893406
Cervical Myelopathy in Hip Fracture Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zachary J Gunderson, MD
- Phone Number: 2193215850
- Email: zgunders@iu.edu
Study Contact Backup
- Name: Rowan Flynn, MD
- Phone Number: 8082641713
Study Locations
-
-
Indiana
-
Fishers, Indiana, United States, 46032
- Recruiting
- Indiana University North Hospital
-
Contact:
- Zachary Gunderson, MD
- Phone Number: 219-321-5850
- Email: zgunders@iu.edu
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Health Methodist Hospital
-
Contact:
- Zachary Gunderson, MD
- Phone Number: 219-321-5850
- Email: zgunders@iu.edu
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Eskenazi Hospital
-
Contact:
- Zachary Gunderson, MD
- Phone Number: 219-321-5850
- Email: zgunders@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI.
A history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of cervical myelopathy on history and physical exam
Time Frame: Once, at time of enrollment
|
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
Time Frame: Once, prior to hospital discharge
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24990
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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