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Treatment of Type II Odontoid Fractures Among the Elderly

A

AOSpine North America Research Network

Status

Completed

Conditions

Spinal Injuries
Neck Injuries

Treatments

Procedure: surgical
Procedure: conservative treatment

Study type

Observational

Funder types

NETWORK
Industry

Identifiers

NCT00266929
07-GOF-05

Details and patient eligibility

About

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients > 64 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.

Full description

Hypotheses are as follows:

  • Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively.
  • The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management.
  • The rate of non union will be greater in the conservative group compared to the surgical group.
  • The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.

Enrollment

159 patients

Sex

All

Ages

64+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All new type II odontoid fractures including those in which the fracture line crosses into the body of C2
  • Age > 64
  • Stable and unstable fractures
  • < 3 months post-injury
  • No previous treatment for an odontoid fracture

Exclusion criteria

  • Pathological fractures unrelated to osteoporosis
  • Severe dementia or severe mental health problems
  • Participation in other trials or unlikely to attend follow-ups

Trial design

159 participants in 2 patient groups

Surgical
Description:
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
Treatment:
Procedure: surgical
Non-surgical
Description:
Subjects treated with non-operative treatment options
Treatment:
Procedure: conservative treatment

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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