Surgery versus a rigid neck collar for odontoid (C2) fractures in adults aged 70 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label, parallel-group non-inferiority trial comparing surgical posterior C1–C2 screw-rod fixation with conservative treatment using a rigid cervical collar in patients aged 70 or older with acute unstable odontoid fractures. Participants are randomized 1:1 with stratification by center and are followed at around 12 weeks and 6 months, with an extra ~2-week postoperative visit for surgical patients; crossover from collar to surgery is permitted if clinically needed. The primary outcome is change in the Barthel Index from baseline to 12 weeks, and secondary outcomes include quality of life (EQ-5D), neck pain (VAS), neck disability (NDI), radiographic healing, treatment compliance, crossover rate, and adverse events. The trial is conducted at several major German spine centers to generate pragmatic, practice-relevant evidence for this older population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 70 years old
* Acute unstable OFs (types II, III as classified by Anderson and d'Alonzo, and atypical)
* Less than two weeks post injury
* Written informed consent

Exclusion Criteria:

* Previous treatment for odontoid fracture
* Concomitant fractures of the subaxial cervical spine necessitating surgery
* Significant comorbidity resulting in inoperability of the patient: i.e. ASA score \> 4
* Neurological compromise due to displaced fracture

Where it's running

• Charité University Hospital Berlin
  Berlin, State of Berlin, Germany Recruiting
• Department of Neurosurgery, University Hospital of Lausitz
  Lausitz, Germany Recruiting
• LMU University Hospital
  Munich, Bavaria, Germany Not yet recruiting
• Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik
  Frankfurt am Main, Hesse, Germany Not yet recruiting
• Department of Neurosurgery, RWTH Aachen University
  Aachen, Germany Not yet recruiting
• Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin Buch
  Berlin, Germany Not yet recruiting

Study contacts

• Study coordinator: Maria Wostrack, Prof. Dr.
• Email: Maria.wostrack@tum.de
• Phone: +498941405386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.