Uppsala Study on Odontoid Fracture Treatment in the Elderly

Spinal Fractures Clinical Trial

— USOFT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02789774
• Other study ID #: USOFT
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2012
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures

Intervention

Procedure:
• Posterior fusion C1-C2
Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.
• Rigid cervical collar
External immobilization of cervical spine in a rigid collar for 12 weeks.

Locations

Country	Name	City	State
Sweden	Malmö University Hospital	Malmö
Sweden	Uppsala University Hospital	Uppsala	Uppsala County

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Kose et al. 2007

Olerud et al. 1999

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI questionnaire)		1 year
Secondary	EQ5D questionnaire		1 year
Secondary	Number of participants that deceased after inclusion		1 year