NCT05360524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

3.5 years

First QC Date

April 5, 2022

Last Update Submit

June 24, 2022

Conditions

Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    3, 6 and 12 month after treatment.

Secondary Outcomes (4)

  • Neck pain .

    3, 6 and 12 month after treatment.

  • C2-C7 Cobb angle

    3, 6 and 12 month after treatment.

  • C7 slope

    3, 6 and 12 month after treatment

  • C2-C7 sagittal vertical axis

    3, 6 and 12 month after treatment

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: Laminectomy alone versus laminectomy and fusion

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

ACTIVE COMPARATOR

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.

Procedure: Laminectomy alone versus laminectomy and fusion

Interventions

Laminectomy alone versus laminectomy and fusionPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, 199093, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 20065985BACKGROUND

  • 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.

    PMID: 23924165BACKGROUND

  • McDonald JW, Sadowsky C. Spinal-cord injury. Lancet. 2002 Feb 2;359(9304):417-25. doi: 10.1016/S0140-6736(02)07603-1.

    PMID: 11844532BACKGROUND

  • 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.

    PMID: 24757474BACKGROUND

  • 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.

    PMID: 29709551BACKGROUND

  • 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.

    PMID: 27597512BACKGROUND

  • 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.

    PMID: 31530900BACKGROUND

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Khaled Mohamed Hassan, Professor

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 5, 2022

First Posted

May 4, 2022

Study Start

May 1, 2022

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)