Uppsala Study on Odontoid Fracture Treatment in the Elderly

Not Applicable

Active, not recruiting

• Conditions: Spinal Fractures
• Interventions: Procedure: Rigid cervical collar; Procedure: Posterior fusion C1-C2

• Registration Number: NCT02789774
• Lead Sponsor: Uppsala University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-03
• Status Verified: 2024-03
• Primary Completion: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Rigid cervical collar	External stabilization of odontoid fracture with a rigid cervical collar for 3 months.
Surgical treatment	Posterior fusion C1-C2	Stabilization of odontoid fracture with posterior fusion C1-C2

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI questionnaire)	1 year

Secondary Outcome Measures

Name	Time	Method
EQ5D questionnaire	1 year
Number of participants that deceased after inclusion	1 year

Trial Locations

Locations (2)

Uppsala University Hospital; 🇸🇪 Uppsala, Uppsala County, Sweden

Malmö University Hospital; 🇸🇪 Malmö, Sweden