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OpenTrials
Completed

NCT Number: NCT00266929

Treatment of Type II Odontoid Fractures Among the Elderly

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.

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Key information

Conditions

Neck Injuries Back Injuries Spinal Injuries Wounds and Injuries

Age range

64 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical

Procedure

surgical treatment of odontoid fractures

Conservative treatment

Procedure

conservative stabilization of fractures

Primary outcomes

  1. Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index

    Time frame: 12 months

  2. Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients

    Time frame: 12 months

  3. Compare the rate of non-union between the surgically and conservatively managed patients

    Time frame: 12 months

Secondary outcomes

  1. Compare the rate of complications

    Time frame: 12 months

  2. Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management

    Time frame: 12 months

  3. Identify risk factors for a poor outcome, independent of treatment intervention

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AOSpine North America Research Network

Network

Collaborators

  • AOSpine North America

Registry information

Official study title

Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 20, 2005
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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