Anterior Odontoid Screw Osteosynthesis in Treatment of Type 2 Odontoid Fracture

NCT03355703 | Completed DMC

• 1 other identifier: Trauma unit
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Odontoid fracture is a common fracture accounting for 10-15% of all cervical fractures. It occurs in bimodal fashion in elderly and young patients. The classification of Anderson and Alonzo provides a guide for prognosis . Type I and type III have a good rate of union, while type II has a poor prognosis due to poor blood supply. Hence, operative fixation is recommended to avoid non-union. Treatment options for type II include anterior odontoid screw fixation and posterior C1-C2 fusion.Despite the excellent rates of bony union in posterior C1-C2 fusion, it is associated with higher morbidity, higher blood loss and significant limitation in the range of motion and rotation of the neck.the aim of the study Is to evaluate clinical and radiological outcome of anterior odontoid screw osteosynthesis in treatment of type 2 odontoid fracture.

Conditions

Odontoid Fracture

Outcome Measures

Primary Outcomes (1)

• Association for the study of internal fixation(AO) neck disability index.

  AO neck disability index is a questionnaire designed to give us information as to how neck pain has affected the ability to manage in everyday life. It consists of ten sections each of them descripes one of daily activity and graded from zero to five the higher the total score the more severity of disability. The sections are pain intensity, personal care , lifting, reading , headache, concentration, work, driving, sleaping, recreation . its developed by Vernon,H .\& Mior,S . (1991)

  1 year

Secondary Outcomes (1)

• Assesment of bony union

  1year

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All cases with type 2 odontoid fracture admitted to trauma unit assiut university hospital

You may qualify if:

• \_ All Type II odontoid fractures in adults .

You may not qualify if:

• Associated fracture body of C2 .
• Reverse type of odontoid fracture pattern.
• Pathological fractures or osteoporotic bone.
• Non-union.
• Short ,kyphotic neck and obese people.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Mohamed Fayez ahmed

Asyut, Nag Hamady, 71511, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Ahmed mohamed fayez

Study Record Dates

• First Submitted: October 21, 2017
• First Posted: November 28, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

EG (1)