Status:
UNKNOWN
Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Odontoid Fracture
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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 hypothes...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03788200
Start Date
June 14 2018
End Date
October 1 2020
Last Update
December 28 2018
Active Locations (1)
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1
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107