Surgery versus a rigid neck collar for odontoid (C2) fractures in adults aged 70 and older
Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
This study will try either posterior C1–C2 surgery or a rigid cervical collar to see which helps adults 70+ with unstable odontoid (C2) fractures recover daily function better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 322 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 16 sites (Munich, Bavaria and 15 other locations) |
| Trial ID | NCT06961578 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 70 years or older with acute (under two weeks) unstable odontoid fractures (Anderson and d'Alonzo types II, III, or atypical) who can give informed consent and have not had prior odontoid treatment.
Not a fit: Patients with severe comorbidity making them inoperable (e.g., ASA > 4), concomitant subaxial fractures that require surgery, neurological compromise from a displaced fracture, or fractures older than two weeks are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the trial could show that a non-surgical collar approach yields similar recovery in daily activities, potentially avoiding surgical risks for some older patients.
How similar studies have performed: Previous observational studies and small trials have produced mixed results and no clear consensus, so this randomized non-inferiority trial addresses an important evidence gap.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Munich, Bavaria and 15 other locations
- 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)
- Charité University Hospital Berlin — Berlin, State of Berlin, Germany (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)
- Department of Orthopaedic and Traumatology, University of Cologne — Cologne, Germany (Not_yet_recruiting)
- Department of Orthopedics, Medical University at Dresden — Dresden, Germany (Not_yet_recruiting)
- Department of Neurosurgery and Spine Surgery, University Hospital Essen — Essen, Germany (Not_yet_recruiting)
- Department of Neurosurgery, University Medical Center Göttingen — Göttingen, Germany (Not_yet_recruiting)
- Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost Halle — Halle, Germany (Not_yet_recruiting)
- Department of Neurosurgery, University Hospital Heidelberg — Heidelberg, Germany (Not_yet_recruiting)
- Department of Neurosurgery, University Hospital of Lausitz — Lausitz, Germany (Recruiting)
- Department of Orthopaedics, Trauma Surgery and Plastic Surgery, University of Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Spine Surgery, Orthopedic Hospital Markgröningen GmbH — Markgröningen, Germany (Not_yet_recruiting)
- BG Trauma Centre, Eberhard Karls University of Tuebingen — Tübingen, Germany (Not_yet_recruiting)
- Spine Center, St. Josefs-Hospital Wiesbaden — Wiesbaden, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Maria Wostrack, Prof. Dr.
- Email: Maria.wostrack@tum.de
- Phone: +498941405386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.