Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Primary Purpose
Tramatic Odontoid Fracture
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Harms technique
Sponsored by
About this trial
This is an interventional treatment trial for Tramatic Odontoid Fracture
Eligibility Criteria
Inclusion Criteria:
- C1-C2 displacement that needs intra-operative reduction
- Short neck not suitable for anterior odontoid screw
- Osteoporotic patients
- Odontoid fracture associated with transverse ligament tear suspected.
- Oblique line of fracture
- Failure of union after conservative treatment.
Exclusion Criteria:
- Associated spinal fractures
- Other comorbidities
Sites / Locations
- Ahmed Salaheldin Mohammed Saro
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
traumatic odontoid fracture
Arm Description
C1 C2 fusion screws
Outcomes
Primary Outcome Measures
evaluation neurological deficit using Frankel grading system within 3 years
grades from A to E and A is the best neurological function while E is the worst neurological function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03768843
Brief Title
Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Official Title
Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
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
Cervical trauma is a common cause of disability following spinal cord injury, especially in athletic populations. The biomechanics in the atlantoaxial joint carry more than 50% of the rotational movement which can be affected in transverse ligament tear associated with odontoid fracture type II. Odontoid fracture type II considered an unstable fracture with a high rate of non-union in conservative treatment. Limitation of the odontoid screws in some cases gives the chance of posterior cervical fixation to have the superior role. Use of polyaxial screws in Harms technique gives the best results in maintaining the majority of the biomechanics.
Purpose: our aim in this study to evaluate Harms technique in those patients regarding pain improvement and restoration of the motor power and to report the complications.
Study design: A retrospective case series study. We Used the Frankel grading system to evaluate the postoperative neurological state.
Detailed Description
After approval of Research Ethics Committee, twelve patients with post-traumatic odontoid fracture type II were scheduled in our Neurosurgery department at Sohag University Hospital for atlantoaxial fusion using polyaxial C1 lateral mass and C2 pedicle screws between January 2015 and January 2018.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tramatic Odontoid Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traumatic odontoid fracture
Arm Type
Other
Arm Description
C1 C2 fusion screws
Intervention Type
Procedure
Intervention Name(s)
Harms technique
Other Intervention Name(s)
C1 C2 fusion
Intervention Description
Atlantoaxial fusion
Primary Outcome Measure Information:
Title
evaluation neurological deficit using Frankel grading system within 3 years
Description
grades from A to E and A is the best neurological function while E is the worst neurological function
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
C1-C2 displacement that needs intra-operative reduction
Short neck not suitable for anterior odontoid screw
Osteoporotic patients
Odontoid fracture associated with transverse ligament tear suspected.
Oblique line of fracture
Failure of union after conservative treatment.
Exclusion Criteria:
Associated spinal fractures
Other comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham A Elsharkawy, Professor
Organizational Affiliation
Sohag faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ahmed Salaheldin Mohammed Saro
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Surgical Outcome of Type II Odontoid Fracture, Harms Technique
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