Odontoid FractureNCT06890130
Outcomes of Fracture Odontoid Management
An observational study of Odontoid Fracture, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Odontoid Fracture
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • Patients who are not available for two year follow-up
- Patients who refuse to participate in the study
About this study
Official title: Long-Term Outcomes of Fracture Odontoid Management in Assiut University
This study aims to evaluate the long-term outcomes of treating patients with odontoid fractures admitted to the Trauma Unit of Assiut University Hospital.
Read the detailed description
study focuses on assessing the long-term results of treatment for patients diagnosed with odontoid fractures. These fractures involve the odontoid process of the second cervical vertebra and can be serious due to their potential impact on spinal stability and neurological function. The study is conducted within the Trauma Unit of Assiut University Hospital, indicating that it involves patients who have been admitted for acute care following such injuries. The long-term outcomes likely include factors such as recovery rates, complications, and the effectiveness of different treatment modalities.
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.
- Conditions
- Odontoid Fracture
- Keywords
- odontoid fracture, management, long term outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of improvement
Percentage of improvement in NDI following conservative and surgical treatment during the follow up visits
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontoid FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelwahab Hassan Hasanien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890130
- Sponsor's protocol ID
- Outcomes Of Fracture Odontoid
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29456915
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Fracture Odontoid Management in Assiut University
- ClinicalTrials.gov ID
- NCT06890130
- Acronym / sponsor ID
- Outcomes Of Fracture Odontoid
- Conditions
- Odontoid Fracture
- Keywords
- odontoid fracture, management, long term outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the long-term outcomes of treating patients with odontoid fractures admitted to the Trauma Unit of Assiut University Hospital.
Detailed description
study focuses on assessing the long-term results of treatment for patients diagnosed with odontoid fractures. These fractures involve the odontoid process of the second cervical vertebra and can be serious due to their potential impact on spinal stability and neurological function. The study is conducted within the Trauma Unit of Assiut University Hospital, indicating that it involves patients who have been admitted for acute care following such injuries. The long-term outcomes likely include factors such as recovery rates, complications, and the effectiveness of different treatment modalities.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- • Patients who are not available for two year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of improvement
Time frame: 2 years
Percentage of improvement in NDI following conservative and surgical treatment during the follow up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 29456915Cutler 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.
- Individual participant dataSharing planned: Undecided
Related trials for Odontoid Fracture
Recruiting
SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
Odontoid Fracture, Elderly
Recruiting
Study on Orthosis in Cervical Spine Fracture Treatment
Cervical Spine Fractures, Cervical Spine Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Odontoid Fracture, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of improvement (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.