Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT03788200
Eligibility Criteria:
Inclusion Criteria:
Patients to be considered for trial enrollment will include those:
1. ages 65 and older;
2. presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
3. deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
4. able to independently cooperate in the completion of all study consents, forms and documents.
5. able to speak, read and write English at an elementary school level
Exclusion Criteria:
Patients to be excluded from trial enrolment include:
1. those with previously documented type II odontoid fracture;
2. those with odontoid fracture related to malignancy or infection;
3. those with associated spinal cord injury
4. those with other cervical, thoracic or lumbar injuries requiring surgical intervention
5. those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03788200
Study Brief:
Protocol Section:
NCT03788200