- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042596
Short Term Outcomes of Fracture Odontoid Management
March 12, 2024 updated by: Ahmed Shaif Al-Huthaifi, Assiut University
Short Term Outcomes of Fracture Odontoid Management in Assuit University Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
patients with completed records, CTs, and Plain radiographs.
Sufficient clinical records with documented NDI, The patient will be evaluated in 2 weeks, 6 weeks , and 3 , 6 months post operative .
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71511
- Assiut University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patient with fracture Odontoid .
Description
Inclusion Criteria:
- all patients with odontoid fractures admitted to Assiut University Hospital - Department of Orthopedics and Trauma between October 2021 and June 2023
Exclusion Criteria:
- patients who are not available for 6 months follow-up and those with insufficient documentation or records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the short term outcomes of Odontoid fracture in skeletally mature patients
Time Frame: 6 months
|
To use the NDI as assessment tool of outcome
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohammad El-Sharkawi, Assiut University
- Study Director: Ahmed Abdelgawaad, Assiut University
- Study Director: Mahmoud Ibrahim, Assiut University
- Principal Investigator: Ahmed Al-huthaifi, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2021
Primary Completion (Actual)
October 6, 2022
Study Completion (Actual)
June 6, 2023
Study Registration Dates
First Submitted
September 5, 2021
First Submitted That Met QC Criteria
September 5, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Outcome of Odontoid fracture
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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