Uppsala Study on Odontoid Fracture Treatment in the Elderly (USOFT)

March 8, 2024 updated by: Uppsala University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Malmö, Sweden, 21428
        • Malmö University Hospital
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75195
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical treatment
Stabilization of odontoid fracture with posterior fusion C1-C2
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.
Other Names:
  • Posterior atlantoaxial fusion
Active Comparator: Conservative treatment
External stabilization of odontoid fracture with a rigid cervical collar for 3 months.
Procedure: Rigid cervical collar
External immobilization of cervical spine in a rigid collar for 12 weeks.
Other Names:
  • cervical orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neck Disability Index (NDI questionnaire)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ5D questionnaire
Time Frame: 1 year
1 year
Number of participants that deceased after inclusion
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Anna-Lena Robinson, MD, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimated)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USOFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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