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

Cervical Spinal Cord Injury Clinical Trial

Official title:

Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05360524
• Other study ID #: Laminectomy vs fusion
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

McDonald JW, Sadowsky C. Spinal-cord injury. Lancet. 2002 Feb 2;359(9304):417-25. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neck pain .	It is assessed by the 100 mm visual analog scale (VAS) score (neck).	3, 6 and 12 month after treatment.
Secondary	C2-C7 Cobb angle	C2-C7 Cobb angle< 10°	3, 6 and 12 month after treatment.
Secondary	C7 slope	C7 slope <10°, the angle between the horizontal plane and the plane of the superior endplate of the C7 vertebral body.	3, 6 and 12 month after treatment
Secondary	C2-C7 sagittal vertical axis	C2-C7 sagittal vertical axis < 4cm, the anterior offset of C2 from C7.	3, 6 and 12 month after treatment