NCT00283998

Brief Summary

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \>/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

4.8 years

First QC Date

January 30, 2006

Last Update Submit

March 25, 2014

Conditions

Odontoid Fractures Type II

Keywords

OdontoidType II fracturesElderly patientsSurgical vs. conservative treatment

Outcome Measures

Primary Outcomes (4)

  • Quality of life using the Neck disability Index

    12 months

  • Quality of life using the SF-36

    12 months

  • Proportion of bony fusion between the two treatments

    6 months

  • Proportion rate of non-union between the two treatments

    6 months

Secondary Outcomes (3)

  • Rate of complications

    12 months

  • Cervical range of motion

    12 months

  • Identify the risk factors for a poor outcome independent of treatment intervention

    12 months

Interventions

surgical versus conservative treatmentPROCEDURE

Surgical treatment of fractures versus conservative stabilization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All new type II odontoid fractures including \< those in which the fracture line crosses into the body of C2 \< as long as it doesn't enter the superior articular process of C2
  • Age 65+
  • Stable and unstable fractures
  • \< 3 months postinjury
  • No previous treatment for an odontoid fracture

You may not qualify if:

  • Pathologic fractures unrelated to osteoporosis
  • Severe dementia or other severe mental health problem if there is no consentable surrogate available
  • Participating in other trials or unlikely to attend follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University SOM: Orthopedics

Atlanta, Georgia, 35037, United States

Location

Study Officials

  • Alexander R Vaccaro, MD

    Th. Jefferson University Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2010

Study Completion

March 1, 2012

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)