Treatment of Type II Odontoid Fractures Among the Elderly

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients > 64 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

Detailed Description
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Hypotheses are as follows: Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively. The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management. The rate of non union will be greater in the conservative group compared to the surgical group. The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.

Official Title
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Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Conditions
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Neck Injuries, Spinal Injuries

Intervention / Treatment
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* Procedure: surgical
* Procedure: conservative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All new type II odontoid fractures including those in which the fracture line crosses into the body of C2 Age > 64 Stable and unstable fractures < 3 months post-injury No previous treatment for an odontoid fracture Exclusion Criteria: Pathological fractures unrelated to osteoporosis Severe dementia or severe mental health problems Participation in other trials or unlikely to attend follow-ups

Ages Eligible for Study
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Minimum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical<br>Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation) | Procedure: surgical<br>* surgical treatment of odontoid fractures<br>|
| Non-surgical<br>Subjects treated with non-operative treatment options | Procedure: conservative treatment<br>* conservative stabilization of fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index |  | 12 months | 
| Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients |  | 12 months | 
| Compare the rate of non-union between the surgically and conservatively managed patients |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the rate of complications |  | 12 months | 
| Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management |  | 12 months | 
| Identify risk factors for a poor outcome, independent of treatment intervention |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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odontoid fx, surgical intervention, conservative treatment, nonunion, odontoid fractures, surgical treatment