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Completed

NCT Number: NCT03768843

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.

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Key information

Conditions

Tramatic Odontoid Fracture

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Salaheldin Mohammed Saro

Sohag, 82511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Harms technique

Procedure

Atlantoaxial fusion

Other names: C1 C2 fusion

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2018
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.