Cervical Myelopathy in Hip Fracture Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Cervical MRI
  Participants whose history and physical exam indicate signs or symptoms of cervical myelopathy will be scheduled for a cervical MRI.
• Другое History & Physical Exam
  A history and physical exam to evaluate for specific signs and symptoms of cervical myelopathy will be performed.

Первичные конечные точки

• Detection of cervical myelopathy on history and physical exam [Срок оценки: Once, at time of enrollment]
• Diagnosis of cervical myelopathy on cervical MRI [Срок оценки: Once, prior to hospital discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 3 центра

• Indiana University North Hospital — Fishers
• Eskenazi Hospital — Indianapolis
• Indiana University Health Methodist Hospital — Indianapolis

Публикации

• 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 26562581

Идентификаторы

NCT: NCT06893406 · 24990

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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