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临床试验/NCT06893406
NCT06893406招募中不适用

Cervical Myelopathy in Hip Fracture Patients

Indiana University6 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
6
主要终点
Detection of cervical myelopathy on history and physical exam

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Cervical MRI (Diagnostic Test)

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.

干预措施: History & Physical Exam (Other)

结局指标

主要结局

Detection of cervical myelopathy on history and physical exam

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Bradbury

Associate Professor of Clinical Neurological Surgery

Indiana University

研究点 (6)

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