NCT05042596

Brief Summary

The aim of this study is to evaluate and assess the short-term outcomes of odontoid fracture cases admitted to trauma unit of Assiut university hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

September 5, 2021

Last Update Submit

March 12, 2024

Conditions

Spine Injury

Keywords

Odontoid fracture, upper cervical fracture, anterior odontoid screw, NDI.

Outcome Measures

Primary Outcomes (1)

  • Assess the short term outcomes of Odontoid fracture in skeletally mature patients

    To use the NDI as assessment tool of outcome

    6 months

Eligibility Criteria

Age2 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient with fracture Odontoid .

You may qualify if:

  • all patients with odontoid fractures admitted to Assiut University Hospital - Department of Orthopedics and Trauma between October 2021 and June 2023

You may not qualify if:

  • patients who are not available for 6 months follow-up and those with insufficient documentation or records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut UNIVERSITY HOSPITAL

Asyut, 71511, Egypt

Location

Related Publications (2)

  • Pal D, Sell P, Grevitt M. Type II odontoid fractures in the elderly: an evidence-based narrative review of management. Eur Spine J. 2011 Feb;20(2):195-204. doi: 10.1007/s00586-010-1507-6. Epub 2010 Sep 12.

    PMID: 20835875RESULT

  • Wang J, Zheng W, Zhang Z, Li C, Zhou Y. [Percutaneous anterior odontoid and transarticular screw fixation for type II odontoid fractures in elderly patients]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2013 Sep;27(9):1090-3. Chinese.

    PMID: 24279021RESULT

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back InjuriesWounds and Injuries

Study Officials

  • Mohammad El-Sharkawi

    Assiut University

    STUDY CHAIR

  • Ahmed Abdelgawaad

    Assiut University

    STUDY DIRECTOR

  • Mahmoud Ibrahim

    Assiut University

    STUDY DIRECTOR

  • Ahmed Al-huthaifi

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 5, 2021

First Posted

September 13, 2021

Study Start

October 6, 2021

Primary Completion

October 6, 2022

Study Completion

June 6, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

EG(1)