Odontoid FractureNCT03355703
Anterior Odontoid Screw Osteosynthesis in Treatment of Type 2 Odontoid Fracture
An observational study of Odontoid Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
Odontoid fracture is a common fracture accounting for 10-15% of all cervical fractures. It occurs in bimodal fashion in elderly and young patients. The classification of Anderson and Alonzo provides a guide for prognosis . Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Odontoid Fracture
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Oct 2019
- How long will I take part?
- 1 Year
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases with type 2 odontoid fracture admitted to trauma unit assiut university hospital
Who may be able to join
- All Type II odontoid fractures in adults .
Who cannot join
- Associated fracture body of C2 .
- Reverse type of odontoid fracture pattern.
- Pathological fractures or osteoporotic bone.
- Non-union.
- Short ,kyphotic neck and obese people.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Anterior Odontoid Screw Osteosynthesis in Treatment of Type 2 Odontoid Fracture
Odontoid fracture is a common fracture accounting for 10-15% of all cervical fractures. It occurs in bimodal fashion in elderly and young patients.
The classification of Anderson and Alonzo provides a guide for prognosis . Type I and type III have a good rate of union, while type II has a poor prognosis due to poor blood supply. Hence, operative fixation is recommended to avoid non-union.
Treatment options for type II include anterior odontoid screw fixation and posterior C1-C2 fusion.Despite the excellent rates of bony union in posterior C1-C2 fusion, it is associated with higher morbidity, higher blood loss and significant limitation in the range of motion and rotation of the neck.the aim of the study Is to evaluate clinical and radiological outcome of anterior odontoid screw osteosynthesis in treatment of type 2 odontoid fracture.
Read the detailed description
Preoperative evaluation:
Full clinical Evaluation and management in trauma unit using Advanced Trauma Life Support protocols.
Full neurological assessment and classification using American Spinal Injury Association score.
Radiological assessment includes antero-posterior and lateral plain cervical radiograph and CT scan for all patients. MRI will be done neurological deficit
Operative technique:
Position:
The patient is placed supine on the operating table and neck is positioned in extension so as to achieve optimum reduction. Intra-operative x-rays are obtained in the Antero_posterior and lateral planes.
Incision:
Longitudinal incision is made at the medial border of the sternomastoid muscle on the right side.The platysma is divided,and the fascia of the sternocleidomastoid is sharply incised along its medial border. Blunt dissection is used to expose the anterior surface of the spinal column at the midcervical level by opening natural planes medial to the carotid artery sheath and lateral to the trachea and esophagus.The fascia of the musculus longus colli is incised in the midline, and the muscle is elevated from the vertebra.Blunt dissection in the retropharyngeal space is used to open a tunnel in front of the vertebra to the C-2 level.
A K-wire is inserted through the incision up to the inferior edge of C-2, under Image, and impacted into the inferior edge of C-2. A K wire is advanced carefully controlled with biplane fluoroscopy from the inferior anterior edge of C-2 through the body of C-2 to the odontoid till its apex. A cannulated drill pit is then used over the wire. The drilled hole is then tapped. The screw, selected based on the measured depth, is placed and tightened firmly monitored fluoroscopically. One screw is biomechanically sufficient for fixation. The wound is checked for hemostasis,and closure completed in layers over a suction drain.
Post-operative care and follow up:
Post-operative collar for 6 weeks. Follow up visits at 2 weeks,2,6,12 months.Clinical and neurological assessment will be done and cervical X-rays will be ordered at each follow up visit.
Functional outcome will be evaluated by Association for the study of internal fixation(AO) neck pain and disability score postoperative and at 1 year follow up.
CT scan will be done for all patients at 1 year to ensure bony union.
- Conditions
- Odontoid Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Association for the study of internal fixation(AO) neck disability index.
AO neck disability index is a questionnaire designed to give us information as to how neck pain has affected the ability to manage in everyday life. It consists of ten sections each of them descripes one of daily activity and graded from zero to five the higher the total score the more severity of disability. The sections are pain intensity, personal care , lifting, reading , headache, concentration, work, driving, sleaping, recreation . its developed by Vernon,H .\& Mior,S . (1991)
Measured: 1 year
Secondary outcomes (1)
Assesment of bony union
Measured by CT scan
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed mohamed fayez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355703
- Sponsor's protocol ID
- Trauma unit
- Status last verified
- May 2020
- First submitted
- 21 Oct 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Anterior Odontoid Screw Osteosynthesis in Treatment of Type 2 Odontoid Fracture
- ClinicalTrials.gov ID
- NCT03355703
- Acronym / sponsor ID
- Trauma unit
- Conditions
- Odontoid Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 28 Nov 2017 (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.
Odontoid fracture is a common fracture accounting for 10-15% of all cervical fractures. It occurs in bimodal fashion in elderly and young patients.
The classification of Anderson and Alonzo provides a guide for prognosis . Type I and type III have a good rate of union, while type II has a poor prognosis due to poor blood supply. Hence, operative fixation is recommended to avoid non-union.
Treatment options for type II include anterior odontoid screw fixation and posterior C1-C2 fusion.Despite the excellent rates of bony union in posterior C1-C2 fusion, it is associated with higher morbidity, higher blood loss and significant limitation in the range of motion and rotation of the neck.the aim of the study Is to evaluate clinical and radiological outcome of anterior odontoid screw osteosynthesis in treatment of type 2 odontoid fracture.
Detailed description
Preoperative evaluation:
Full clinical Evaluation and management in trauma unit using Advanced Trauma Life Support protocols.
Full neurological assessment and classification using American Spinal Injury Association score.
Radiological assessment includes antero-posterior and lateral plain cervical radiograph and CT scan for all patients. MRI will be done neurological deficit
Operative technique:
Position:
The patient is placed supine on the operating table and neck is positioned in extension so as to achieve optimum reduction. Intra-operative x-rays are obtained in the Antero_posterior and lateral planes.
Incision:
Longitudinal incision is made at the medial border of the sternomastoid muscle on the right side.The platysma is divided,and the fascia of the sternocleidomastoid is sharply incised along its medial border. Blunt dissection is used to expose the anterior surface of the spinal column at the midcervical level by opening natural planes medial to the carotid artery sheath and lateral to the trachea and esophagus.The fascia of the musculus longus colli is incised in the midline, and the muscle is elevated from the vertebra.Blunt dissection in the retropharyngeal space is used to open a tunnel in front of the vertebra to the C-2 level.
A K-wire is inserted through the incision up to the inferior edge of C-2, under Image, and impacted into the inferior edge of C-2. A K wire is advanced carefully controlled with biplane fluoroscopy from the inferior anterior edge of C-2 through the body of C-2 to the odontoid till its apex. A cannulated drill pit is then used over the wire. The drilled hole is then tapped. The screw, selected based on the measured depth, is placed and tightened firmly monitored fluoroscopically. One screw is biomechanically sufficient for fixation. The wound is checked for hemostasis,and closure completed in layers over a suction drain.
Post-operative care and follow up:
Post-operative collar for 6 weeks. Follow up visits at 2 weeks,2,6,12 months.Clinical and neurological assessment will be done and cervical X-rays will be ordered at each follow up visit.
Functional outcome will be evaluated by Association for the study of internal fixation(AO) neck pain and disability score postoperative and at 1 year follow up.
CT scan will be done for all patients at 1 year to ensure bony union.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases with type 2 odontoid fracture admitted to trauma unit assiut university hospital
Key inclusion criteria (1 listed)
- All Type II odontoid fractures in adults .
Key exclusion criteria (5 listed)
- Associated fracture body of C2 .
- Reverse type of odontoid fracture pattern.
- Pathological fractures or osteoporotic bone.
- Non-union.
- Short ,kyphotic neck and obese people.
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
Association for the study of internal fixation(AO) neck disability index.
Time frame: 1 year
AO neck disability index is a questionnaire designed to give us information as to how neck pain has affected the ability to manage in everyday life. It consists of ten sections each of them descripes one of daily activity and graded from zero to five the higher the total score the more severity of disability. The sections are pain intensity, personal care , lifting, reading , headache, concentration, work, driving, sleaping, recreation . its developed by Vernon,H .\& Mior,S . (1991)
1 secondary outcome
Assesment of bony union
Time frame: 1year
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 12 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Odontoid Fracture, 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 5 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 12 May 2020. 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?
Association for the study of internal fixation(AO) neck disability index. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.