Pedicle ScrewNCT05855642
Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique
An observational study of Pedicle Screw and CPS, run by Assiut University.
Trial summary
The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pedicle Screw, CPS
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024
Who may be able to join
- traumatic sub axial cervical spine injuries.
- degenerative cervical spine disorders necessitating cervical fusion
Who cannot join
- congenital anomaly of the cervical spine
- scoliotic deformity of the cervical spine
- sever osteoporosis
- congenital malformation of the pedicle.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique (TDT)
The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.
Read the detailed description
The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.
Although a number of studies have evaluated the morphometric of cervical pedicles to support accurate placement of pedicle screws , the results are inconclusive. Therefore, several techniques using lateral fluoroscopy , pedicle axis view by oblique fluoroscopy , laminoframinotomy and computer-assisted navigation systems for CPS insertion have been advocated. Determining an appropriate entry point for screw insertion as well as a proper trajectory angle of the screw on the axial plane is important for successful pedicle screw placement. Here, we present our method using a fashioned triad- dependent technique (TDT) which is a combination of three methods 1-preoperative planning of the selected pedicle using 3-diamentional multi-slice CT to measure pedicle transverse angle (PTA) , pedicle outer diameter(POD)and pedicle trajectory -contralateral lamina angle 2-AP and oblique fluoroscopy to determine pedicle entry point (PEP), parallelism to vertebral end plate and 4 direction cortical violation (medial, lateral, superior, inferior) 3-interlaminar confirmatory key hole for tactile cue of medial ,superior, and inferior borders of the pedicle and related nerve root to evaluate the accuracy and safety of pedicle screw placement in patients with sub axial cervical spine disorders treated using our method.
- Conditions
- Pedicle Screw, CPS
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 |
|---|---|---|
| Patients | All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological accuracy
- X-ray AP and lateral
- MSCT: Placements of pedicle screws will be assessed using CT data and outcome-based classifications:
2 mm increment classification:
- Type 0 (good): Screw within the pedicle medullary canal.
- Type 1 (acceptable): Minimal penetration of the pedicle wall by the screw (<2 mm of medial or lateral cortical perforation or anterior cortex perforation).
- Type 2 (unacceptable): Less than half of the diameter of the screw was outside the pedicle wall (2-4 mm of perforation).
- Type 3 (grievous): More than half of the diameter of the screw was outside the pedicle wall (>4 mm of perforation) (spinal cord injury or screw abutting vertebral artery).
Measured: Immediately post Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelrahman Saleh El Attar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855642
- Sponsor's protocol ID
- ASTPSF
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotani Y, Cunningham BW, Abumi K, McAfee PC. Biomechanical analysis of cervical stabilization systems. An assessment of transpedicular screw fixation in the cervical spine. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2529-39. doi: 10.1097/00007632-199411001-00007.
PubMed 7855677Jones EL, Heller JG, Silcox DH, Hutton WC. Cervical pedicle screws versus lateral mass screws. Anatomic feasibility and biomechanical comparison. Spine (Phila Pa 1976). 1997 May 1;22(9):977-82. doi: 10.1097/00007632-199705010-00009.
PubMed 9152447Karaikovic EE, Daubs MD, Madsen RW, Gaines RW Jr. Morphologic characteristics of human cervical pedicles. Spine (Phila Pa 1976). 1997 Mar 1;22(5):493-500. doi: 10.1097/00007632-199703010-00005.
PubMed 9076880Ludwig SC, Kramer DL, Vaccaro AR, Albert TJ. Transpedicle screw fixation of the cervical spine. Clin Orthop Relat Res. 1999 Feb;(359):77-88. doi: 10.1097/00003086-199902000-00009.
PubMed 10078131Bredow J, Beyer F, Oppermann J, Kraus B, Meyer C, Stein G, Eysel P, Koy T. A novel classification of screw placement accuracy in the cervical spine. Technol Health Care. 2016 Nov 14;24(6):919-925. doi: 10.3233/THC-161246.
PubMed 27497461Aoude AA, Fortin M, Figueiredo R, Jarzem P, Ouellet J, Weber MH. Methods to determine pedicle screw placement accuracy in spine surgery: a systematic review. Eur Spine J. 2015 May;24(5):990-1004. doi: 10.1007/s00586-015-3853-x. Epub 2015 Mar 7.
PubMed 25749690Jo DJ, Seo EM, Kim KT, Kim SM, Lee SH. Cervical pedicle screw insertion using the technique with direct exposure of the pedicle by laminoforaminotomy. J Korean Neurosurg Soc. 2012 Nov;52(5):459-65. doi: 10.3340/jkns.2012.52.5.459. Epub 2012 Nov 30.
PubMed 23323166Yukawa Y, Kato F, Ito K, Horie Y, Hida T, Nakashima H, Machino M. Placement and complications of cervical pedicle screws in 144 cervical trauma patients using pedicle axis view techniques by fluoroscope. Eur Spine J. 2009 Sep;18(9):1293-9. doi: 10.1007/s00586-009-1032-7. Epub 2009 Jun 2.
PubMed 19488794
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique (TDT)
- ClinicalTrials.gov ID
- NCT05855642
- Acronym / sponsor ID
- ASTPSF
- Conditions
- Pedicle Screw, CPS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 11 May 2023 (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 use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.
Detailed description
The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.
Although a number of studies have evaluated the morphometric of cervical pedicles to support accurate placement of pedicle screws , the results are inconclusive. Therefore, several techniques using lateral fluoroscopy , pedicle axis view by oblique fluoroscopy , laminoframinotomy and computer-assisted navigation systems for CPS insertion have been advocated. Determining an appropriate entry point for screw insertion as well as a proper trajectory angle of the screw on the axial plane is important for successful pedicle screw placement. Here, we present our method using a fashioned triad- dependent technique (TDT) which is a combination of three methods 1-preoperative planning of the selected pedicle using 3-diamentional multi-slice CT to measure pedicle transverse angle (PTA) , pedicle outer diameter(POD)and pedicle trajectory -contralateral lamina angle 2-AP and oblique fluoroscopy to determine pedicle entry point (PEP), parallelism to vertebral end plate and 4 direction cortical violation (medial, lateral, superior, inferior) 3-interlaminar confirmatory key hole for tactile cue of medial ,superior, and inferior borders of the pedicle and related nerve root to evaluate the accuracy and safety of pedicle screw placement in patients with sub axial cervical spine disorders treated using our method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024
Key inclusion criteria (2 listed)
- traumatic sub axial cervical spine injuries.
- degenerative cervical spine disorders necessitating cervical fusion
Key exclusion criteria (4 listed)
- congenital anomaly of the cervical spine
- scoliotic deformity of the cervical spine
- sever osteoporosis
- congenital malformation of the pedicle.
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
Radiological accuracy
Time frame: Immediately post Operative
A. X-ray AP and lateral B. MSCT: Placements of pedicle screws will be assessed using CT data and outcome-based classifications: 2 mm increment classification: * Type 0 (good): Screw within the pedicle medullary canal. * Type 1 (acceptable): Minimal penetration of the pedicle wall by the screw (<2 mm of medial or lateral cortical perforation or anterior cortex perforation). * Type 2 (unacceptable): Less than half of the diameter of the screw was outside the pedicle wall (2-4 mm of perforation). * Type 3 (grievous): More than half of the diameter of the screw was outside the pedicle wall (>4 mm of perforation) (spinal cord injury or screw abutting vertebral artery).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 7855677Kotani Y, Cunningham BW, Abumi K, McAfee PC. Biomechanical analysis of cervical stabilization systems. An assessment of transpedicular screw fixation in the cervical spine. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2529-39. doi: 10.1097/00007632-199411001-00007.
- Background: PubMed 9152447Jones EL, Heller JG, Silcox DH, Hutton WC. Cervical pedicle screws versus lateral mass screws. Anatomic feasibility and biomechanical comparison. Spine (Phila Pa 1976). 1997 May 1;22(9):977-82. doi: 10.1097/00007632-199705010-00009.
- Background: PubMed 9076880Karaikovic EE, Daubs MD, Madsen RW, Gaines RW Jr. Morphologic characteristics of human cervical pedicles. Spine (Phila Pa 1976). 1997 Mar 1;22(5):493-500. doi: 10.1097/00007632-199703010-00005.
- Background: PubMed 10078131Ludwig SC, Kramer DL, Vaccaro AR, Albert TJ. Transpedicle screw fixation of the cervical spine. Clin Orthop Relat Res. 1999 Feb;(359):77-88. doi: 10.1097/00003086-199902000-00009.
- Background: PubMed 27497461Bredow J, Beyer F, Oppermann J, Kraus B, Meyer C, Stein G, Eysel P, Koy T. A novel classification of screw placement accuracy in the cervical spine. Technol Health Care. 2016 Nov 14;24(6):919-925. doi: 10.3233/THC-161246.
- Background: PubMed 25749690Aoude AA, Fortin M, Figueiredo R, Jarzem P, Ouellet J, Weber MH. Methods to determine pedicle screw placement accuracy in spine surgery: a systematic review. Eur Spine J. 2015 May;24(5):990-1004. doi: 10.1007/s00586-015-3853-x. Epub 2015 Mar 7.
- Background: PubMed 23323166Jo DJ, Seo EM, Kim KT, Kim SM, Lee SH. Cervical pedicle screw insertion using the technique with direct exposure of the pedicle by laminoforaminotomy. J Korean Neurosurg Soc. 2012 Nov;52(5):459-65. doi: 10.3340/jkns.2012.52.5.459. Epub 2012 Nov 30.
- Background: PubMed 19488794Yukawa Y, Kato F, Ito K, Horie Y, Hida T, Nakashima H, Machino M. Placement and complications of cervical pedicle screws in 144 cervical trauma patients using pedicle axis view techniques by fluoroscope. Eur Spine J. 2009 Sep;18(9):1293-9. doi: 10.1007/s00586-009-1032-7. Epub 2009 Jun 2.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pedicle Screw and CPS, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud S El Attar (00201014919050, attar@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological accuracy (time frame: Immediately post Operative). 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 NCT05855642, which also lists 8 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 11 May 2023.