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Surgical Outcome of Type II Odontoid Fracture, Harms Technique

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ClinicalTrials.gov Identifier: NCT03768843
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
ahmed salaheldin mohammed saro, Sohag University

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.


Condition or disease Intervention/treatment Phase
Tramatic Odontoid Fracture Procedure: Harms technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Outcome of Type II Odontoid Fracture, Harms Technique
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
traumatic odontoid fracture
C1 C2 fusion screws
Procedure: Harms technique
Atlantoaxial fusion
Other Name: C1 C2 fusion




Primary Outcome Measures :
  1. evaluation neurological deficit using Frankel grading system within 3 years [ Time Frame: 3 years ]
    grades from A to E and A is the best neurological function while E is the worst neurological function



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. C1-C2 displacement that needs intra-operative reduction
  2. Short neck not suitable for anterior odontoid screw
  3. Osteoporotic patients
  4. Odontoid fracture associated with transverse ligament tear suspected.
  5. Oblique line of fracture
  6. Failure of union after conservative treatment.

Exclusion Criteria:

  • Associated spinal fractures
  • Other comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768843


Locations
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Egypt
Ahmed Salaheldin Mohammed Saro
Sohag, Egypt, 82511
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Hisham A Elsharkawy, Professor Sohag faculty of medicine

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Responsible Party: ahmed salaheldin mohammed saro, Assistant professor of neurosurgery, Sohag University
ClinicalTrials.gov Identifier: NCT03768843     History of Changes
Other Study ID Numbers: Sohag3
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries