Surgical versus conservative treatment of odontoid fractures in the elderly: a prospective cohort study

Completed

Conditions: dens fracture
Fractured odontoid process
10009720

Registration Number: NL-OMON50404

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 152

Inclusion Criteria

- At least 55 years old
- Acute type II and III odontoid fracture according to Anderson and d*Alonzo
classification (possibly in combination with other fractures); diagnosed using
computed tomography
- Less than two weeks after injury
- Informed consent

Exclusion Criteria

- Rheumatoid arthritis
- Ankylosing spondylitis
- Previous treatment for odontoid fracture
- Communication with patient is hampered (e.g. language barrier, severe
cognitive impairment, coma)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Clinical outcome, scored by the Neck Disability Index at 52 weeks after start<br /><br>of treatment<br /><br>- Fracture healing, assessing union (union or non-union) and stability at 52<br /><br>weeks after start of treatment<br /><br><br /><br>Union will be defined by evidence of bone trabeculae crossing the fracture site<br /><br>and absence of sclerotic borders adjacent to the fracture site, assessed using<br /><br>computed tomography (CT).<br /><br><br /><br>Fracture stability will be assessed using cervical dynamic X-rays in lateral<br /><br>projection. A maximum of 2 mm movement at the fracture site is considered<br /><br>stable.<br /><br><br /><br>Imaging data will be sent to the coordinating centre and will be judged by<br /><br>independent assessors (neuroradiologists) who are blinded to the results.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical: Myelopathy Disability Index, VAS neck pain score, SF-36, EQ5D, DS14<br /><br>(psychometric properties), IPQ-K (illness perception), Likert<br /><br>Radiological: Fracture displacement, grade of osteoporosis in C2, grade of<br /><br>degeneration of C1-C2 facet joints, pseudoarthrosis<br /><br>General: Complications, reinterventions (secondary surgery, surgery after<br /><br>failed conservative treatment)</p><br>