Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 12/29/2018 |
| Start Date: | June 14, 2018 |
| End Date: | October 2020 |
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.
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.
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
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