Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Status unconfirmed · Not applicable
Conditions studied: Odontoid Fracture
In brief
This prospective study addresses one of the most controversial topics in the treatment of cervical spine trauma: the management of type II odontoid process fractures in the elderly. It is the hypothesis that surgical treatment will result in improved functional outcome measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore, it is hypothesized that surgical treatment of odontoid process fractures will limit hospital re-admissions and development of medical complications secondary to prolonged immobilization in a cervical orthosis and delayed surgery related to late fracture displacement, which are often associated with non-operative care. Additionally, data from this study will be useful in identifying patient-specific predictors of improved outcome which can be used to optimize treatment algorithms and more effectively counsel patients who sustain these injuries.
Key facts
- Study ID
- NCT03788200
- Run by
- Rothman Institute Orthopaedics
- People needed
- 200
- Starts
- 2018-06-14
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2018-12-28
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients to be considered for trial enrollment will include those:
- ages 65 and older;
- presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
- deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
- able to independently cooperate in the completion of all study consents, forms and documents.
- able to speak, read and write English at an elementary school level
You may not qualify if…
- Patients to be excluded from trial enrolment include:
- those with previously documented type II odontoid fracture;
- those with odontoid fracture related to malignancy or infection;
- those with associated spinal cord injury
- those with other cervical, thoracic or lumbar injuries requiring surgical intervention
- those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation
Where it is running
- Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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