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Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability

Primary Purpose

Cervical Spinal Cord Injury

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laminectomy alone versus laminectomy and fusion
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spinal Cord Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with traumatic cervical spine cord injury admitted to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery regardless of age, mechanism of injury or neurological status changes.

Exclusion Criteria:

  1. Associated cervical spine bony or ligamentous injury.
  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

Sites / Locations

  • Faculty of Medicine Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laminectomy alone in patients with traumatic cervical spinal cord injury without instability

Laminectomy and fusion in patients with traumatic cervical spinal cord injury without instability

Arm Description

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.

Outcomes

Primary Outcome Measures

Neurological recovery.
It is assessed by the improvement (changes) in American Spinal Injury Association (ASIA) motor score). it is based on the motor function score of the 10 pairs of key muscles in the upper and lower limbs, with 5 points for each muscle and 100 points in total.

Secondary Outcome Measures

Neck pain .
It is assessed by the 100 mm visual analog scale (VAS) score (neck).
C2-C7 Cobb angle
C2-C7 Cobb angle< 10°
C7 slope
C7 slope <10°, the angle between the horizontal plane and the plane of the superior endplate of the C7 vertebral body.
C2-C7 sagittal vertical axis
C2-C7 sagittal vertical axis < 4cm, the anterior offset of C2 from C7.

Full Information

First Posted
April 5, 2022
Last Updated
June 24, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05360524
Brief Title
Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability
Official Title
Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of study is to compare clinical and radiological outcomes of laminectomy alone to laminectomy and fusion in the treatment of traumatic cervical spinal cord injury without instability.
Detailed Description
Cervical spinal cord injury (CSCI) without instability tends to be caused by a hyperextension force to the neck. This type of injury has been increasing as the elderly population is dramatically increasing. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laminectomy alone in patients with traumatic cervical spinal cord injury without instability
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Laminectomy and fusion in patients with traumatic cervical spinal cord injury without instability
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laminectomy alone versus laminectomy and fusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurological recovery.
Description
It is assessed by the improvement (changes) in American Spinal Injury Association (ASIA) motor score). it is based on the motor function score of the 10 pairs of key muscles in the upper and lower limbs, with 5 points for each muscle and 100 points in total.
Time Frame
3, 6 and 12 month after treatment.
Secondary Outcome Measure Information:
Title
Neck pain .
Description
It is assessed by the 100 mm visual analog scale (VAS) score (neck).
Time Frame
3, 6 and 12 month after treatment.
Title
C2-C7 Cobb angle
Description
C2-C7 Cobb angle< 10°
Time Frame
3, 6 and 12 month after treatment.
Title
C7 slope
Description
C7 slope <10°, the angle between the horizontal plane and the plane of the superior endplate of the C7 vertebral body.
Time Frame
3, 6 and 12 month after treatment
Title
C2-C7 sagittal vertical axis
Description
C2-C7 sagittal vertical axis < 4cm, the anterior offset of C2 from C7.
Time Frame
3, 6 and 12 month after treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with traumatic cervical spine cord injury admitted to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery regardless of age, mechanism of injury or neurological status changes. Exclusion Criteria: Associated cervical spine bony or ligamentous injury. Associated primary focal anterior compression of the cervical spinal cord (clear disc herniation). Associated head injury. Kyphotic cervical spine as measured by C2-C7 Cobb angle on X-ray. Previous surgery of the cervical spine. Patients who refuse to participate in the study Patients who are mentally incompetent or unable to comply with the one year follow up regimen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Mohamed Hassan, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine Assiut University
City
Assiut
ZIP/Postal Code
199093
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20065985
Citation
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.
Results Reference
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PubMed Identifier
23924165
Citation
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.
Results Reference
background
PubMed Identifier
11844532
Citation
McDonald JW, Sadowsky C. Spinal-cord injury. Lancet. 2002 Feb 2;359(9304):417-25. doi: 10.1016/S0140-6736(02)07603-1.
Results Reference
background
PubMed Identifier
24757474
Citation
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.
Results Reference
background
PubMed Identifier
29709551
Citation
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.
Results Reference
background
PubMed Identifier
27597512
Citation
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.
Results Reference
background
PubMed Identifier
31530900
Citation
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.
Results Reference
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Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability

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