Cervical MyelopathyNCT06893406
Cervical Myelopathy in Hip Fracture Patients
A study testing Cervical MRI and History & Physical Exam in people with Cervical Myelopathy and Hip Fractures, run by Indiana University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cervical Myelopathy, Hip Fractures
- What is being tested?
- Cervical MRI and History & Physical Exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2025to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neurologic or cognitive disorder explaining the fall (dementia, Parkinson's disease, delirium, etc.)
- Syncopal fall or fall caused by stroke or a heart condition
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University North Hospital
Fishers, Indiana, 46032
Eskenazi Hospital
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the 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
- Being tested
- Cervical MRI, History & Physical Exam
- Keywords
- Hip fracture, Cervical myelopathy
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical MRIDiagnostic test
Participants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI.
History & Physical ExamOther
A history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cervical MRI; Other: History & Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once, prior to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 May 2025
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Bradbury, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893406
- Sponsor's protocol ID
- 24990
- Status last verified
- May 2026
- First submitted
- 18 Mar 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26562581
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Myelopathy in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT06893406
- Acronym / sponsor ID
- 24990
- Conditions
- Cervical Myelopathy, Hip Fractures
- Keywords
- Hip fracture, Cervical myelopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation for Cervical Myelopathy | Experimental | Diagnostic Test: Cervical MRI, Other: History & Physical ExamHip 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Neurologic or cognitive disorder explaining the fall (dementia, Parkinson's disease, delirium, etc.)
- Syncopal fall or fall caused by stroke or a heart condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical MRIParticipants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI. | Diagnostic test | Evaluation for Cervical Myelopathy |
| History & Physical ExamA history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed. | Other | Evaluation for Cervical Myelopathy |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 26562581Radcliff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical MRI and History & Physical Exam in people with Cervical Myelopathy and Hip Fractures, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cervical myelopathy on history and physical exam (time frame: Once, at time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06893406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.