Back to resultsRandomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Primary Purpose
Odontoid Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bracing
posterior C1-C2 instrumented fusion
Sponsored by
About this trial
This is an interventional treatment trial for Odontoid Fracture
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
post-injury bracing with rigid cervical collar
posterior C1-2 instrumented fusion
Arm Description
Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
Outcomes
Primary Outcome Measures
neck disability
Measured by validated outcome measure NDI (Neck Disability Index)
Secondary Outcome Measures
Full Information
NCT ID
NCT03788200
First Posted
December 26, 2018
Last Updated
December 26, 2018
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03788200
Brief Title
Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Official Title
Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontoid Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
post-injury bracing with rigid cervical collar
Arm Type
Active Comparator
Arm Description
Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
Arm Title
posterior C1-2 instrumented fusion
Arm Type
Active Comparator
Arm Description
Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
Intervention Type
Procedure
Intervention Name(s)
Bracing
Intervention Description
Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
Intervention Type
Procedure
Intervention Name(s)
posterior C1-C2 instrumented fusion
Intervention Description
Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
Primary Outcome Measure Information:
Title
neck disability
Description
Measured by validated outcome measure NDI (Neck Disability Index)
Time Frame
6 months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
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