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Clinical Trials/NCT02800278
NCT02800278CompletedNot Applicable

Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

Centre Hospitalier Universitaire de Nice2 sites in 1 country30 target enrollmentStarted: January 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status

Study Overview

Brief Summary

Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :

  • to describe the different type of odontoid fracture and to characterize bone status in elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma energy.
  • To describe short and long term outcomes

Detailed Description

All patients over 65 y admitted for low trauma odontoid fracture will be consecutively included in the study after informed consent. The investigators will record:

  • clinical risk factor of osteoporosis and health habits including accomodation
  • type of fracture and characterization of the odontoid fracture on imaging (standard X ray / MRI / QCT)
  • Bone status : bone mineral density on DXA, lab tests for secondary osteoporosis check-up, previous vertebral fracture on VFA or X ray
  • osteoporosis managment : nutrition, vitamin D, anti-osteoporotic drugs
  • treatment of the fracture : surgical / non surgical
  • adverse event during hospitalization
  • lenght of hospital stay
  • type of discharge

Follow-up à 3 and 12 months : dead vs alive ; accomodation ; autonomy ; new fracture

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • all patients over 65 y admitted for low traumat odontoid fracture

Exclusion Criteria

  • patient < 65 y
  • traumatic odontoid fracture

Outcomes

Primary Outcomes

bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status

Time Frame: from date of inclusion until to 3 weeks after the event. Inclusion will be proposed within 2 weeks after the fracture

clinical risk factor of osteoporosis, prevalent clinical osteoporotic fracture, bone mineral density measured by DXA, vertebral fracture assessment to detect other vertebral fracture, serum concentration in 25OHvitamin D

Secondary Outcomes

  • mortality(during hospitalization - 3 and 12 months after inclusion)
  • morbidity(during hospitalization - 3 and 12 months after inclusion)
  • loss of autonomy(discharge, 3 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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