Short-Term Outcomes Of Subaxial Cervical Injuries

Cervical Spinal Cord Injury Clinical Trial

Official title:

Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678803
• Other study ID #: Subaxial Cervical Injuries
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The subaxial cervical spine consists of levels C3 through C7 and includes both the bony anatomy as well as the ligamentous anatomy. Injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both (1). Cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident (2). Devastating sequelae of subaxial cervical spine trauma include quadriplegia, functional loss, and permanent disability

Description:

Initially, all patients with subaxial cervical spine fractures require immobilization in a rigid cervical orthosis (2). Patients receiving conservative treatment are often prescribed a rigid cervical or cervicothoracic orthosis for 6 to 12 weeks with regular follow-up and interval radiographs to assess alignment.

Patients with fractures deemed unstable or neurologic compromise should undergo decompression and stabilization. Intervention within 24 hours of injury leads to better improvement in ASIA scores (3). The recent AO Spine Subaxial Classification system relies essentially on MSCT evaluation (Reference). However, MRI is superior to CT scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine (4).

Even though the investigators receive and treat a large number of patients with various subaxial cervical injuries in Assiut University Hospital each year, there is no consensus about the best treatment options and uncertainty about the outcome of these treatments.

In this study, the participants will assess the short-term outcomes of all patients with subaxial cervical fractures who will be admitted to the participants' center regardless of the neurological status or treatment type used.

The participants will also create a detailed prospective database to be used for another later study on the long-term outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.

Exclusion Criteria:

• 1- Patients who refuse to participate in the study 2- Patients who are not available for 6 weeks follow up

Related Conditions & MeSH terms

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

Intervention

Other:
• xrays and CT
A dedicated sheet will be used to record patients' data including all demographic data, detailed analysis of the mechanism of injury, time of injury, time and details of surgery (if any), neurological status on admission and all radiological findings. All patients will undergo plain X-rays and CT imaging. Patients with suspected discoligamentous injuries and/or neurological deficits will also be assessed by MRI.

Locations

Country	Name	City	State
Egypt	Peternabil049@Gmail.Com	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Feuchtbaum E, Buchowski J, Zebala L. Subaxial cervical spine trauma. Curr Rev Musculoskelet Med. 2016 Dec;9(4):496-504. doi: 10.1007/s12178-016-9377-0. — View Citation

Kwon BK, Vaccaro AR, Grauer JN, Fisher CG, Dvorak MF. Subaxial cervical spine trauma. J Am Acad Orthop Surg. 2006 Feb;14(2):78-89. doi: 10.5435/00124635-200602000-00003. — View Citation

Pourtaheri S, Emami A, Sinha K, Faloon M, Hwang K, Shafa E, Holmes L Jr. The role of magnetic resonance imaging in acute cervical spine fractures. Spine J. 2014 Nov 1;14(11):2546-53. doi: 10.1016/j.spinee.2013.10.052. Epub 2013 Nov 22. — View Citation

Schroeder GD, Vaccaro AR. Cervical Spine Injuries in the Athlete. J Am Acad Orthop Surg. 2016 Sep;24(9):e122-33. doi: 10.5435/JAAOS-D-15-00716. — View Citation

Shaheen AA, Omar MT, Vernon H. Cross-cultural adaptation, reliability, and validity of the Arabic version of neck disability index in patients with neck pain. Spine (Phila Pa 1976). 2013 May 1;38(10):E609-15. doi: 10.1097/BRS.0b013e31828b2d09. — View Citation

Stauffer ES. Subaxial injuries. Clin Orthop Relat Res. 1989 Feb;(239):30-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center	Neck disability index It is a standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score	1 year