Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability
NCT ID: NCT05360524
Last Updated: 2022-06-29
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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ACTIVE_NOT_RECRUITING
NA
42 participants
INTERVENTIONAL
2022-05-01
2025-12-01
Brief Summary
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Detailed Description
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Although surgery has become the preferred method for management of traumatic unstable cervical spine injury, the treatment of spinal cord injury (SCI) without instability such as fracture, dislocation, and ligamentous injury, however, remains controversial.
Before deciding for surgical or conservative treatment, one should understand the pathophysiology of SCI. Traumatic SCI is dependent on primary damage, such as the dynamic mechanistic force and static pre-existing or concurrent cord compression, and secondary damage, such as edema, ischemia, and inflammation, which lead to demyelination of axons, apoptosis of neural cells, and glial scar formation in the spinal cord.
Advocates of conservative treatment believe that decompression is not effective here, because the compression may have existed before the injury in asymptomatic patients. Therefore, the symptoms develop after a CSCI without instability are probably not a result of the compression itself. On the other hands advocates of surgical treatment believe that decompression could prevent secondary cord damage due to the vicious cycle of "ischemia-edema-ischemia". However, faced with a patient with neurologic dysfunction MRI evidence of cervical spinal cord compression, decompressive surgery is a practical treatment option.
Since these injuries are stable, why to add fusion to laminectomy when it is possible to perform laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laminectomy alone in patients with traumatic cervical spinal cord injury without instability
laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Laminectomy alone versus laminectomy and fusion
laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Laminectomy and fusion in patients with traumatic cervical spinal cord injury without instability
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Laminectomy alone versus laminectomy and fusion
laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Interventions
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Laminectomy alone versus laminectomy and fusion
laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Associated primary focal anterior compression of the cervical spinal cord (clear disc herniation).
3. Associated head injury.
4. Kyphotic cervical spine as measured by C2-C7 Cobb angle on X-ray.
5. Previous surgery of the cervical spine.
6. Patients who refuse to participate in the study
7. Patients who are mentally incompetent or unable to comply with the one year follow up regimen
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Sayed Hamed Mohammed
Physician
Principal Investigators
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Khaled Mohamed Hassan, Professor
Role: STUDY_CHAIR
Assiut University
Locations
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Faculty of Medicine Assiut University
Asyut, , Egypt
Countries
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References
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Kawano O, Ueta T, Shiba K, Iwamoto Y. Outcome of decompression surgery for cervical spinal cord injury without bone and disc injury in patients with spinal cord compression: a multicenter prospective study. Spinal Cord. 2010 Jul;48(7):548-53. doi: 10.1038/sc.2009.179. Epub 2010 Jan 12.
Chikuda H, Ohtsu H, Ogata T, Sugita S, Sumitani M, Koyama Y, Matsumoto M, Toyama Y; OSCIS investigators. Optimal treatment for spinal cord injury associated with cervical canal stenosis (OSCIS): a study protocol for a randomized controlled trial comparing early versus delayed surgery. Trials. 2013 Aug 7;14:245. doi: 10.1186/1745-6215-14-245.
McDonald JW, Sadowsky C. Spinal-cord injury. Lancet. 2002 Feb 2;359(9304):417-25. doi: 10.1016/S0140-6736(02)07603-1.
Lee HJ, Kim HS, Nam KH, Han IH, Cho WH, Choi BK. Neurologic Outcome of Laminoplasty for Acute Traumatic Spinal Cord Injury without Instability. Korean J Spine. 2013 Sep;10(3):133-7. doi: 10.14245/kjs.2013.10.3.133. Epub 2013 Sep 30.
Passias PG, Vasquez-Montes D, Poorman GW, Protopsaltis T, Horn SR, Bortz CA, Segreto F, Diebo B, Ames C, Smith J, LaFage V, LaFage R, Klineberg E, Shaffrey C, Bess S, Schwab F; ISSG. Predictive model for distal junctional kyphosis after cervical deformity surgery. Spine J. 2018 Dec;18(12):2187-2194. doi: 10.1016/j.spinee.2018.04.017. Epub 2018 Apr 27.
Fehlings MG, Santaguida C, Tetreault L, Arnold P, Barbagallo G, Defino H, Kale S, Zhou Q, Yoon TS, Kopjar B. Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies. Spine J. 2017 Jan;17(1):102-108. doi: 10.1016/j.spinee.2016.08.019. Epub 2016 Sep 3.
ASIA and ISCoS International Standards Committee. The 2019 revision of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)-What's new? Spinal Cord. 2019 Oct;57(10):815-817. doi: 10.1038/s41393-019-0350-9. Epub 2019 Sep 17. No abstract available.
Other Identifiers
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Laminectomy vs fusion
Identifier Type: -
Identifier Source: org_study_id
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