Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws
NCT ID: NCT04196153
Last Updated: 2020-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-10-10
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neuronavigation / O-arm group
Under neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted.
Pedicle screws instrumentation
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
Cervical distractor screws group
pedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously.
Pedicle screws instrumentation
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
Interventions
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Pedicle screws instrumentation
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.
18 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
Responsible Party
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Principal Investigators
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Mohammed A Khashab, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Orthopedic, College of Medicine, KSAU-HS
Locations
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King Abdulaziz Medical City
Jeddah, Eastern Province, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. doi: 10.1302/0301-620X.41B2.248. No abstract available.
Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. doi: 10.2106/00004623-200010000-00013.
Liljenqvist UR, Halm HF, Link TM. Pedicle screw instrumentation of the thoracic spine in idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Oct 1;22(19):2239-45. doi: 10.1097/00007632-199710010-00008.
Krag MH, Beynnon BD, Pope MH, DeCoster TA. Depth of insertion of transpedicular vertebral screws into human vertebrae: effect upon screw-vertebra interface strength. J Spinal Disord. 1988;1(4):287-94. doi: 10.1097/00002517-198800140-00002.
Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
Broom MJ, Banta JV, Renshaw TS. Spinal fusion augmented by luque-rod segmental instrumentation for neuromuscular scoliosis. J Bone Joint Surg Am. 1989 Jan;71(1):32-44.
Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF. Techniques and accuracy of thoracolumbar pedicle screw placement. World J Orthop. 2014 Apr 18;5(2):112-23. doi: 10.5312/wjo.v5.i2.112. eCollection 2014 Apr 18.
Vaccaro AR, Rizzolo SJ, Balderston RA, Allardyce TJ, Garfin SR, Dolinskas C, An HS. Placement of pedicle screws in the thoracic spine. Part II: An anatomical and radiographic assessment. J Bone Joint Surg Am. 1995 Aug;77(8):1200-6. doi: 10.2106/00004623-199508000-00009.
Verma R, Krishan S, Haendlmayer K, Mohsen A. Functional outcome of computer-assisted spinal pedicle screw placement: a systematic review and meta-analysis of 23 studies including 5,992 pedicle screws. Eur Spine J. 2010 Mar;19(3):370-5. doi: 10.1007/s00586-009-1258-4. Epub 2010 Jan 6.
Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.
Kim TT, Drazin D, Shweikeh F, Pashman R, Johnson JP. Clinical and radiographic outcomes of minimally invasive percutaneous pedicle screw placement with intraoperative CT (O-arm) image guidance navigation. Neurosurg Focus. 2014 Mar;36(3):E1. doi: 10.3171/2014.1.FOCUS13531.
Luo TD, Polly DW Jr, Ledonio CG, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years or Younger Using Navigation and Intraoperative CT. Clin Spine Surg. 2016 Apr;29(3):E135-8. doi: 10.1097/BSD.0000000000000230.
Scarone P, Vincenzo G, Distefano D, Del Grande F, Cianfoni A, Presilla S, Reinert M. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. J Neurosurg Spine. 2018 Oct;29(4):397-406. doi: 10.3171/2018.1.SPINE17927. Epub 2018 Jul 6.
Tajsic T, Patel K, Farmer R, Mannion RJ, Trivedi RA. Spinal navigation for minimally invasive thoracic and lumbosacral spine fixation: implications for radiation exposure, operative time, and accuracy of pedicle screw placement. Eur Spine J. 2018 Aug;27(8):1918-1924. doi: 10.1007/s00586-018-5587-z. Epub 2018 Apr 17.
Other Identifiers
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kashabmo
Identifier Type: -
Identifier Source: org_study_id
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