NCT06890130

Brief Summary

This study aims to evaluate the long-term outcomes of treating patients with odontoid fractures admitted to the Trauma Unit of Assiut University Hospital.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started May 2025

Status
not yet recruiting

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

Study Progress61%
May 2025Dec 2026

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 17, 2025

Last Update Submit

March 17, 2025

Conditions

Keywords

odontoid fracturemanagementlong term outcomes

Outcome Measures

Primary Outcomes (1)

  • Percentage of improvement

    Percentage of improvement in NDI following conservative and surgical treatment during the follow up visits

    2 years

Study Arms (1)

All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthop

This population likely includes individuals of various ages and backgrounds who have experienced trauma leading to this specific type of fracture. The study may focus on patients who have undergone different treatment strategies, such as surgical intervention or conservative management, to assess the effectiveness and outcomes of these approaches over time. The demographic characteristics of the population could include age, gender, cause of injury, and pre-existing health conditions, which might influence treatment outcomes.

Eligibility Criteria

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

The study population consists of patients admitted to the Trauma Unit of Assiut University Hospital with diagnosed odontoid fractures. This population likely includes individuals of various ages and backgrounds who have experienced trauma leading to this specific type of fracture. The study may focus on patients who have undergone different treatment strategies, such as surgical intervention or conservative management, to assess the effectiveness and outcomes of these approaches over time. The demographic characteristics of the population could include age, gender, cause of injury, and pre-existing health conditions, which might influence treatment outcomes.

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 2 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 two year follow-up
  • Patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident Orthopaedic and Trauma Surgery

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

May 1, 2025

Primary Completion

October 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03