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OpenTrials
Completed

NCT Number: NCT00283998

Comparing Surgical to Conservative Management in the 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 >/= 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.

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Key information

Conditions

Odontoid Fractures Type II

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University SOM: Orthopedics

Atlanta, Georgia, 35037, United States

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 < 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

Exclusion criteria

  • 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

Treatment and study plan

surgical versus conservative treatment

Procedure

Surgical treatment of fractures versus conservative stabilization

Primary outcomes

  1. Quality of life using the Neck disability Index

    Time frame: 12 months

  2. Quality of life using the SF-36

    Time frame: 12 months

  3. Proportion of bony fusion between the two treatments

    Time frame: 6 months

  4. Proportion rate of non-union between the two treatments

    Time frame: 6 months

Secondary outcomes

  1. Rate of complications

    Time frame: 12 months

  2. Cervical range of motion

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AOSpine North America

Registry information

Official study title

Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Jan 31, 2006
Registry last updated
Mar 26, 2014

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.