Subaxial Cervical Traumatic Injuries

Cervical Injury Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297395
• Other study ID #: Cervical Traumatic Inj
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Peter Philip Phily Ishaq, Resident
• Phone: 01276176649
• Email: Peter.15235761[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital.

Description:

Injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both. Cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident . The subaxial cervical spine is a common site of cervical injury with more than 50 % of injuries being located between C5 and C7 MRI is superior to CT scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine There are a couple of classification systems that have been devised The first is the Subaxial Injury Classification System (SLIC). This classification stratifies the type of fracture, the competency of the DLC, and the patient's neurologic status with numerical values to determine the course of treatment.

A second classification system is the AO Spine Subaxial Cervical Spine Injury Classification. The AO Spine SCICS classifies injuries based on 4 parameters: injury morphology, facet involvement, neurological status, and case-specific modifiers 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 .

Although we receive and treat a large number of patients with various subaxial cervical traumatic injuries in Assiut University Hospital each year, there is uncertainty about the midterm outcome of the treatment we provide.

In this study, The investigators will assess the mid-term outcomes of all patients with subaxial cervical traumatic injuries who complete a minimum one year follow up regardless of the neurological status or treatment type used.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presenting with subaxial cervical spine traumatic injuries with and without cervical cord injury who complete a minimum of one year follow up

Exclusion Criteria:

• Patients who refuse to participate in the study Patients with pathological fractures

Related Conditions & MeSH terms

• Cervical Injury Spine
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Aebi M. Surgical treatment of upper, middle and lower cervical injuries and non-unions by anterior procedures. Eur Spine J. 2010 Mar;19 Suppl 1(Suppl 1):S33-9. doi: 10.1007/s00586-009-1120-8. Epub 2009 Oct 14. — View Citation

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

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

Sadiqi S, Oner FC. A disease-specific patient reported outcome instrument for spine trauma is developed, validated and available! Re: Andrzejowski et al. Measuring functional outcomes in major trauma: can we do better? Eur J Trauma Emerg Surg. 2023 Jun;49(3):1605-1606. doi: 10.1007/s00068-022-02167-8. Epub 2022 Nov 15. No abstract available. Erratum In: Eur J Trauma Emerg Surg. 2023 Mar 9;: — 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

Vaccaro AR, Koerner JD, Radcliff KE, Oner FC, Reinhold M, Schnake KJ, Kandziora F, Fehlings MG, Dvorak MF, Aarabi B, Rajasekaran S, Schroeder GD, Kepler CK, Vialle LR. AOSpine subaxial cervical spine injury classification system. Eur Spine J. 2016 Jul;25(7):2173-84. doi: 10.1007/s00586-015-3831-3. Epub 2015 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of improvement	Percentage of improvement in NDI (Arabic version) following conservative and surgical treatment during the follow up visits	Baseline
Secondary	Patient Outcomes	AO Spine PROST	Baseline
Secondary	Complication	Mortality rate	Baseline
Secondary	rehabilitation	Improvement of neurological deficit by ASIA score	Baseline
Secondary	Complication	Incidence and rate of complications	Baseline
Secondary	rehabilitation	Return to work and activity of daily living.	Baseline
Secondary	Complication	Need for admission to the Intensive Care unit.	Baseline
Secondary	Complication	Post traumatic respiratory distress.	Baseline
Secondary	Complication	Fracture healing - pseudarthrosis - implant failure.	Baseline