Spine InjuryNCT05042596

Short Term Outcomes of Fracture Odontoid Management

An observational study of Spine Injury, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 2 to 100 years
Conditions the study is for: Spine Injury
How many people: 24 participants
Where: 1 siteEgypt
Study dates: 6 Oct 2021to 6 Jun 2023
Phase: Observational
Are there results?: None posted in the registry

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 2 to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patient with fracture Odontoid .

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Assiut UNIVERSITY HOSPITAL
Asyut, 71511

Other trials in Egypt

About this study

Official title: 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.

Read the 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 .

Conditions: Spine Injury
Keywords: Odontoid fracture, upper cervical fracture, anterior odontoid screw, NDI.
Medical subject headings: Spinal Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the short term outcomes of Odontoid fracture in skeletally mature patients
To use the NDI as assessment tool of outcome
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 20216 Jun 2023

First posted13 Sep 2021
Study start6 Oct 2021
Primary completion6 Oct 2022
Study completion6 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Spine InjuryStudies 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: Case only
Time perspective: Prospective
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05042596
Sponsor's protocol ID: Outcome of Odontoid fracture
Status last verified: Mar 2024
First submitted: 5 Sep 2021
Last updated: 13 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 20835875
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.
PubMed 24279021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Recruiting
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
Acute Neurological Injury, Acute Medical Conditions

All Spine Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short Term Outcomes of Fracture Odontoid Management in Assuit University Hospital
ClinicalTrials.gov ID: NCT05042596
Acronym / sponsor ID: Outcome of Odontoid fracture
Conditions: Spine Injury
Keywords: Odontoid fracture, upper cervical fracture, anterior odontoid screw, NDI.
Study type: Observational
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 6 Oct 2021 (actual)
Primary completion: 6 Oct 2022 (actual)
Study completion: 6 Jun 2023 (actual)
First posted: 13 Sep 2021 (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.

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.

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 design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 2 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patient with fracture Odontoid .

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

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

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Results publication: PubMed 20835875Pal 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.
Results publication: PubMed 24279021Wang 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.

Related trials for Spine Injury

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
Recruiting
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
Acute Neurological Injury, Acute Medical Conditions

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. This study is not recruiting at the moment.

Mohammad El-Sharkawi study chair

Assiut University

Ahmed Abdelgawaad study director

Assiut University

Mahmoud Ibrahim study director

Assiut University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Injury, run by Assiut University at 1 site in Egypt.

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 1 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess the short term outcomes of Odontoid fracture in skeletally mature patients (time frame: 6 months). 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 NCT05042596, which also lists 2 linked publications.

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 13 Mar 2024.