Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

NCT02800278 | Unknown

• 1 other identifier: CHU de Nice RHUM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Odontoid Fracture; Osteoporosis; Surgery

Outcome Measures

Primary Outcomes (1)

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

  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

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

Secondary Outcomes (3)

• 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

Interventions

observational OTHER

describe bone status and outcome of odontoid fracture

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients over 65 y admitted for low traumat odontoid fracture

You may qualify if:

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

You may not qualify if:

• patient \< 65 y
• traumatic odontoid fracture

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• veronique breuil, MD, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

veronique Breuil, MD PhD

CONTACT

33 4 920 35 512; breuil.v@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 15, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)