Mid-Term Outcomes Of Fracture Odontoid Management in Assiut University

Cervical Spine Fracture Clinical Trial

Official title:

Mid-Term Outcomes Of Fracture Odontoid Management in Assiut University

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05842694
• Other study ID #: follow up of Odontoid fracture
• Status: Enrolling by invitation
• Start date: May 10, 2023
• Est. completion date: June 2024

Study information

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

Clinical Trial Summary

The aim of this study is to evaluate and assess the mid-term outcomes of treating odontoid fracture cases admitted to the Trauma Unit of Assiut University Hospital.

Description:

Odontoid fractures are common fractures of the cervical spine, accounting for 10-15% of all cervical spine fractures. It has a bimodal age distribution as it occurs in both elderly and young patients. The injury generally occurs as a result of strong flexion and extension movement in addition to axial overload. Flexion generally results in anterior subluxation, while extension results in posterior subluxation.

It was classified by Anderson and D'Alonzo Classification in 1974 into three types according to the fracture location. A newer classification was introduced which offered a clearer distinction between type-II and type-III fractures. In this new classification, Type II fractures were further divided into 3 subtypes. The 3 subtypes are labelled A, B, and C. Type II fractures are usually treated surgically through either anterior or posterior approach depending on the fracture pattern as they are characterized by a higher rate of non-union compared to type I and III being in a watershed level between the vertebral and the internal carotid arteries. Nevertheless, the literature is still confusing about the results of anterior surgery in odontoid fractures.

In a recent study by Cutler et al., anterior fixation of odontoid fracture was associated with high morbidity and mortality. In another study, the most commonly reported major complications after odontoid fracture surgery in the elderly include cardiac failure, deep venous thrombosis , stroke, pneumonia, respiratory failure, liver failure, and severe infection.

Despite the fact that we receive and treat a large number of patients with various types of odontoid fractures in Assiut University Hospital, there is no consensus about the best treatment options and uncertainty about the mid and long term outcome of these treatments.

In this study, the investigators will assess the mid-term outcomes (minimum of one year) to all patients with odontoid fracture who are admitted to the Trauma Unit in Assiut University Hospital regardless the treatment type.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied

Exclusion Criteria:

• Patients who are not available for one year follow-up Patients who refuse to participate in the study

Related Conditions & MeSH terms

• Cervical Spine Fracture
• Fractures, Bone
• Spinal Fractures

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Chi YL, Wang XY, Xu HZ, Lin Y, Huang QS, Mao FM, Ni WF, Wang S, Dai LY. Management of odontoid fractures with percutaneous anterior odontoid screw fixation. Eur Spine J. 2007 Aug;16(8):1157-64. doi: 10.1007/s00586-007-0331-0. Epub 2007 Mar 3. — View Citation

Cutler HS, Guzman JZ, Lee NJ, Kothari P, Kim JS, Shin JI, Leven DM, Cho SK. Short-Term Complications of Anterior Fixation of Odontoid Fractures. Global Spine J. 2018 Feb;8(1):47-56. doi: 10.1177/2192568217698132. Epub 2017 May 16. — View Citation

Grauer JN, Shafi B, Hilibrand AS, Harrop JS, Kwon BK, Beiner JM, Albert TJ, Fehlings MG, Vaccaro AR. Proposal of a modified, treatment-oriented classification of odontoid fractures. Spine J. 2005 Mar-Apr;5(2):123-9. doi: 10.1016/j.spinee.2004.09.014. — View Citation

Julien TD, Frankel B, Traynelis VC, Ryken TC. Evidence-based analysis of odontoid fracture management. Neurosurg Focus. 2000 Jun 15;8(6):e1. doi: 10.3171/foc.2000.8.6.2. — View Citation

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum In: J Manipulative Physiol Ther 1992 Jan;15(1):followi. — View Citation

White AP, Hashimoto R, Norvell DC, Vaccaro AR. Morbidity and mortality related to odontoid fracture surgery in the elderly population. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S146-57. doi: 10.1097/BRS.0b013e3181d830a4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow up of patients with odontoid fracture using neck disability index	Percentage of improvement in neck disability index following conservative and surgical treatment during the follow up visits	baseline
Secondary	rate of complication	Fracture healing; Incidence and rate of complications (e.g. non-union, post-operative infections, C1-2 Instability, etc…..) Return to work/activity of daily living	baseline