Surgical Outcome of Type II Odontoid Fracture, Harms Technique

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.

Study Overview

• Status: Completed
• Conditions: Tramatic Odontoid Fracture
• Intervention / Treatment: Procedure: Harms technique

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Ahmed Salaheldin Mohammed Saro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: traumatic odontoid fracture; C1 C2 fusion screws	Procedure: Harms technique; Atlantoaxial fusion; Other Names: C1 C2 fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Hisham A Elsharkawy, Professor, Sohag faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Sohag3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No