NCT05842694

Brief Summary

The aim of this study is to evaluate and assess the mid-term outcomes of treating odontoid fracture cases admitted to the Trauma Unit of Assiut University Hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

March 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

March 31, 2023

Last Update Submit

May 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • follow up of patients with odontoid fracture using neck disability index

    Percentage of improvement in neck disability index following conservative and surgical treatment during the follow up visits

    baseline

Secondary Outcomes (1)

  • rate of complication

    baseline

Eligibility Criteria

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

All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied

You may qualify if:

  • All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied

You may not qualify if:

  • Patients who are not available for one year follow-up Patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (6)

  • Julien TD, Frankel B, Traynelis VC, Ryken TC. Evidence-based analysis of odontoid fracture management. Neurosurg Focus. 2000 Jun 15;8(6):e1. doi: 10.3171/foc.2000.8.6.2.

    PMID: 16859271BACKGROUND
  • Chi YL, Wang XY, Xu HZ, Lin Y, Huang QS, Mao FM, Ni WF, Wang S, Dai LY. Management of odontoid fractures with percutaneous anterior odontoid screw fixation. Eur Spine J. 2007 Aug;16(8):1157-64. doi: 10.1007/s00586-007-0331-0. Epub 2007 Mar 3.

    PMID: 17334793BACKGROUND
  • Grauer JN, Shafi B, Hilibrand AS, Harrop JS, Kwon BK, Beiner JM, Albert TJ, Fehlings MG, Vaccaro AR. Proposal of a modified, treatment-oriented classification of odontoid fractures. Spine J. 2005 Mar-Apr;5(2):123-9. doi: 10.1016/j.spinee.2004.09.014.

    PMID: 15749611BACKGROUND
  • Cutler HS, Guzman JZ, Lee NJ, Kothari P, Kim JS, Shin JI, Leven DM, Cho SK. Short-Term Complications of Anterior Fixation of Odontoid Fractures. Global Spine J. 2018 Feb;8(1):47-56. doi: 10.1177/2192568217698132. Epub 2017 May 16.

    PMID: 29456915BACKGROUND
  • White AP, Hashimoto R, Norvell DC, Vaccaro AR. Morbidity and mortality related to odontoid fracture surgery in the elderly population. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S146-57. doi: 10.1097/BRS.0b013e3181d830a4.

    PMID: 20407346BACKGROUND
  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PMID: 1834753BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 31, 2023

First Posted

May 6, 2023

Study Start

May 10, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations