Cervical Pedicle ScrewNCT06445348
Analysis of Sub Axial Cervical Pedicle Spine Based on CT
An observational study of Cervical Pedicle Screw, run by Assiut University.
Trial summary
The aim of study to analyze morphometry of sub axial cervical spine pedicle in an Egyptian population based on computed tomography (CT) and thus asses the safety and feasibility of cervical pedicle screw in the sub axial cervical spine Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Cervical Pedicle Screw
- What is being tested?
- Cervical pedicle screw
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to 12 Jun 2027
- 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 16 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Sample size was calculated using Epi- Info7. According to results of previous study (put ref.) , the pullout strength failed by fracture of pedicle screw in 40% of patients undergoing cervical spine CT. Based on this percentage, confidence limits of 7% and a confidence level of 80%, the sample needed for the study was estimated to be about 80 patients.
Who may be able to join
- Individuals from 16 to 65 years old present to Assuit university hospital and undergo cervical spine CT scan for unrelated cause
Who cannot join
- individuals with a history of cervical spine abnormalities.
- individuals with previous cervical spine injury
- individuals with congenital or developmental malformations of cervical spine patients with inflammatory. infectious, neoplastic condition
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Morphometric Analysis of Sub Axial Cervical Spine Pedicle in Egyptian Population
The aim of study to analyze morphometry of sub axial cervical spine pedicle in an Egyptian population based on computed tomography (CT) and thus asses the safety and feasibility of cervical pedicle screw in the sub axial cervical spine
Read the detailed description
Cervical pedicle screw (CPS) fixation is found to be superior compared with lateral mass screws because it provides more axial, bending and torsional stability and has a low risk of loosening with cyclical loading . Despite biomechanical superiority, CPS fixation is not universally accepted among surgeon s because their accuracy and safety remain technically challenging because of the close proximity of vital structures as spinal cord and vertebral artery and inherent variability in pedicle at each level. In addition. limited space is available for screw placement because of complex of cervical spine vertebrae. Therefore, the risk of complication due to screw violation of the adjacent vascular and neural structures is expected to be high when performing the operation without a clear understanding of morphometric characteristics of the pedicle .Morphometry of the cervical pedicles was studied before using cadavers but comparative computed tomography (CT) data from the age matched population shown significant differences. Recent advances in CT have made anatomic measurements more accurate. The present study was undertaken to determine the 3-dimensional pedicle geometry by calculating variables like pedicle length (PL). Pedicle height (PH). Pedicle width (PW), Pedicle axis length (PAL), Pedicle transverse angulation (PTA), Pedicle sagittal angulation (PSA), Superior pedicle distance (SPD), and lateral pedicle distance (LPD). Fortunately, computed tomography (CT) scanning become a routine preoperative examination in spinal surgery patients.
- Conditions
- Cervical Pedicle Screw
- Being tested
- Cervical pedicle screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical pedicle screwDevice
cervical pedicle screw
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of feasibility of sub axial cervical spine pedicle
Morphometric Analysis of sub axial cervical spine pedicle in Egyptian population
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 Dec 2026 (estimated)
- Primary completion21 May 2027 (estimated)
- Study completion12 Jun 2027 (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 Cervical Pedicle ScrewStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Atef Mikhaeel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445348
- Sponsor's protocol ID
- Cervical pedicle screw
- Status last verified
- Sep 2026
- First submitted
- 31 May 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farooque K, Yadav R, Chowdhury B, Gamanagatti S, Kumar A, Meena PK. Computerized Tomography-Based Morphometric Analysis of Subaxial Cervical Spine Pedicle in Asymptomatic Indian Population. Int J Spine Surg. 2018 Aug 3;12(2):112-120. doi: 10.14444/5017. eCollection 2018 Apr.
PubMed 30276069
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphometric Analysis of Sub Axial Cervical Spine Pedicle in Egyptian Population
- ClinicalTrials.gov ID
- NCT06445348
- Acronym / sponsor ID
- Cervical pedicle screw
- Conditions
- Cervical Pedicle Screw
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 21 May 2027 (estimated)
- Study completion
- 12 Jun 2027 (estimated)
- First posted
- 6 Jun 2024 (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 study to analyze morphometry of sub axial cervical spine pedicle in an Egyptian population based on computed tomography (CT) and thus asses the safety and feasibility of cervical pedicle screw in the sub axial cervical spine
Detailed description
Cervical pedicle screw (CPS) fixation is found to be superior compared with lateral mass screws because it provides more axial, bending and torsional stability and has a low risk of loosening with cyclical loading . Despite biomechanical superiority, CPS fixation is not universally accepted among surgeon s because their accuracy and safety remain technically challenging because of the close proximity of vital structures as spinal cord and vertebral artery and inherent variability in pedicle at each level. In addition. limited space is available for screw placement because of complex of cervical spine vertebrae. Therefore, the risk of complication due to screw violation of the adjacent vascular and neural structures is expected to be high when performing the operation without a clear understanding of morphometric characteristics of the pedicle .Morphometry of the cervical pedicles was studied before using cadavers but comparative computed tomography (CT) data from the age matched population shown significant differences. Recent advances in CT have made anatomic measurements more accurate. The present study was undertaken to determine the 3-dimensional pedicle geometry by calculating variables like pedicle length (PL). Pedicle height (PH). Pedicle width (PW), Pedicle axis length (PAL), Pedicle transverse angulation (PTA), Pedicle sagittal angulation (PSA), Superior pedicle distance (SPD), and lateral pedicle distance (LPD). Fortunately, computed tomography (CT) scanning become a routine preoperative examination in spinal surgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Sample size was calculated using Epi- Info7. According to results of previous study (put ref.) , the pullout strength failed by fracture of pedicle screw in 40% of patients undergoing cervical spine CT. Based on this percentage, confidence limits of 7% and a confidence level of 80%, the sample needed for the study was estimated to be about 80 patients.
Key inclusion criteria (1 listed)
- Individuals from 16 to 65 years old present to Assuit university hospital and undergo cervical spine CT scan for unrelated cause
Key exclusion criteria (3 listed)
- individuals with a history of cervical spine abnormalities.
- individuals with previous cervical spine injury
- individuals with congenital or developmental malformations of cervical spine patients with inflammatory. infectious, neoplastic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical pedicle screwcervical pedicle screw | Device | – |
Primary outcome
Assessment of feasibility of sub axial cervical spine pedicle
Time frame: Baseline
Morphometric Analysis of sub axial cervical spine pedicle in Egyptian population
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 3 Sep 2026.
- Background: PubMed 30276069Farooque K, Yadav R, Chowdhury B, Gamanagatti S, Kumar A, Meena PK. Computerized Tomography-Based Morphometric Analysis of Subaxial Cervical Spine Pedicle in Asymptomatic Indian Population. Int J Spine Surg. 2018 Aug 3;12(2):112-120. doi: 10.14444/5017. eCollection 2018 Apr.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pedicle Screw, 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 3 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 3 Sep 2026. 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?
Contact Michael Mikhaeel, Resident (01283635331, michaelatef936@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of feasibility of sub axial cervical spine pedicle (time frame: Baseline). 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 NCT06445348, 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 3 Sep 2026.