Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

• Conditions: Osteoporosis; Odontoid Fracture; Surgery

• Registration Number: NCT02800278
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-18
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-10
• Last Update Submitted: 2016-06-10
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Primary Completion: 2018-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• patient < 65 y
• traumatic odontoid fracture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone status at the time of odontoid fracture: bone mineral density, prevalent osteoporotic fracture, vitamin D status	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 Outcome Measures

Name	Time	Method
loss of autonomy	discharge, 3 and 12 months	lenght of hospital stay, type of discharge (home, nursing home, rehabilitation bed care, institutionalized accomodation
mortality	during hospitalization - 3 and 12 months after inclusion	mortality after odontoid fracture during hospitalization and at 3 and 12 monts
morbidity	during hospitalization - 3 and 12 months after inclusion	incident osteoporotic fracture, adverse event such as infection, cardiovascular event, neurological event

Trial Locations

Locations (1)

CHU; 🇫🇷 Nice, France