A Study to Evaluate Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-000036
NCT ID: NCT03788200
Sponsor Protocol Number: 2018Kepler
About this study
The purpose of this study is to evaluate Posterior C1-2 Fusion versus bracing alone for treatment 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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 Criteria:
- Those individuals with previously documented type II odontoid fracture.
- Those individuals whose odontoid fracture is related to malignancy or infection.
- Those individuals with associated spinal cord injury.
- Those individuals with other cervical, thoracic or lumbar injuries requiring surgical intervention.
- Those individuals with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Arjun Sebastian, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available