Status:
NOT_YET_RECRUITING
SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
St. Josefs-Hospital Wiesbaden GmbH
Medical University of Cologne
Conditions:
Odontoid Fracture
Elderly
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures ...
Detailed Description
The SCORE study is a multicenter, randomized, controlled, open-label, parallel-group non-inferiority trial designed to provide evidence on whether conservative treatment is non-inferior to surgical st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT06961578
Start Date
June 1 2025
End Date
June 1 2028
Last Update
May 8 2025
Active Locations (16)
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1
LMU University Hospital
Munich, Bavaria, Germany, 81377
2
Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik
Frankfurt am Main, Hesse, Germany, 60389
3
Department of Neurosurgery, RWTH Aachen University
Aachen, Germany
4
Charité University Hospital Berlin
Berlin, Germany, 10117