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Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly

Not Applicable
Conditions
Odontoid Fracture
Registration Number
NCT03788200
Lead Sponsor
Rothman Institute Orthopaedics
Brief Summary

This prospective study addresses one of the most controversial topics in the treatment of cervical spine trauma: the management of type II odontoid process fractures in the elderly. It is the hypothesis that surgical treatment will result in improved functional outcome measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore, it is hypothesized that surgical treatment of odontoid process fractures will limit hospital re-admissions and development of medical complications secondary to prolonged immobilization in a cervical orthosis and delayed surgery related to late fracture displacement, which are often associated with non-operative care. Additionally, data from this study will be useful in identifying patient-specific predictors of improved outcome which can be used to optimize treatment algorithms and more effectively counsel patients who sustain these injuries.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria

Patients to be considered for trial enrollment will include those:

  1. ages 65 and older;
  2. presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
  3. deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
  4. able to independently cooperate in the completion of all study consents, forms and documents.
  5. able to speak, read and write English at an elementary school level
Exclusion Criteria

Patients to be excluded from trial enrolment include:

  1. those with previously documented type II odontoid fracture;
  2. those with odontoid fracture related to malignancy or infection;
  3. those with associated spinal cord injury
  4. those with other cervical, thoracic or lumbar injuries requiring surgical intervention
  5. those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
neck disability6 months post randomization

Measured by validated outcome measure NDI (Neck Disability Index)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rothman Institute

🇺🇸

Philadelphia, Pennsylvania, United States

Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States

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