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Uppsala Study on Odontoid Fracture Treatment in the Elderly

NCT02789774 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Spinal Fractures

Interventions

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.

PROCEDURE

Rigid cervical collar

External immobilization of cervical spine in a rigid collar for 12 weeks.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Anna-Lena Robinson, MD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789774 on ClinicalTrials.gov