Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

Surgery Clinical Trial

— FOOP  

Official title:

Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800278
• Other study ID #: CHU de Nice RHUM
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2016
• Last updated: June 10, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: veronique Breuil, MD PhD
• Phone: 33 4 920 35 512
• Email: breuil.v[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patient < 65 y

• traumatic odontoid fracture

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Odontoid Fracture
• Osteoporosis
• Surgery

Intervention

Other:
• observational
describe bone status and outcome of odontoid fracture

Locations

Country	Name	City	State
France	CHU	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	mortality	mortality after odontoid fracture during hospitalization and at 3 and 12 monts	during hospitalization - 3 and 12 months after inclusion	No
Secondary	morbidity	incident osteoporotic fracture, adverse event such as infection, cardiovascular event, neurological event	during hospitalization - 3 and 12 months after inclusion	No
Secondary	loss of autonomy	lenght of hospital stay, type of discharge (home, nursing home, rehabilitation bed care, institutionalized accomodation	discharge, 3 and 12 months	No