Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique

NCT05855642 | Unknown

• 1 other identifier: ASTPSF
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pedicle Screw; CPS

Outcome Measures

Primary Outcomes (1)

• Radiological accuracy

  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).

  Immediately post Operative

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• traumatic sub axial cervical spine injuries.
• degenerative cervical spine disorders necessitating cervical fusion

You may not qualify if:

• congenital anomaly of the cervical spine
• scoliotic deformity of the cervical spine
• sever osteoporosis
• congenital malformation of the pedicle.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 7855677 BACKGROUND

• Jones 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.

  PMID: 9152447 BACKGROUND

• Karaikovic 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.

  PMID: 9076880 BACKGROUND

• Ludwig 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.

  PMID: 10078131 BACKGROUND

• Bredow 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.

  PMID: 27497461 BACKGROUND

• Aoude 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.

  PMID: 25749690 BACKGROUND

• Jo 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.

  PMID: 23323166 BACKGROUND

• Yukawa 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.

  PMID: 19488794 BACKGROUND

Central Study Contacts

Mahmoud S El Attar

CONTACT

00201014919050; attar@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share