Uppsala Study on Odontoid Fracture Treatment in the Elderly

Study Overview
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Brief Summary
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A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.

Detailed Description
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50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while minimally clinical important difference (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group. Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.

Official Title
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Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly

Conditions
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Spinal Fractures

Intervention / Treatment
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* Procedure: Posterior fusion C1-C2
* Procedure: Rigid cervical collar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation. Exclusion Criteria: Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical treatment<br>Stabilization of odontoid fracture with posterior fusion C1-C2 | Procedure: Posterior fusion C1-C2<br>* Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.<br>* Other names: Posterior atlantoaxial fusion;|
| Active Comparator: Conservative treatment<br>External stabilization of odontoid fracture with a rigid cervical collar for 3 months. | Procedure: Rigid cervical collar<br>* External immobilization of cervical spine in a rigid collar for 12 weeks.<br>* Other names: cervical orthosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI questionnaire) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D questionnaire |  | 1 year | 
| Number of participants that deceased after inclusion |  | 1 year |