SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
Recruiting now · Not applicable
Conditions studied: Odontoid Fracture, Elderly
In brief
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 are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are: * Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks? * What are the differences in pain, disability, and quality of life between the two treatments? The study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing. Participants will: * be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment * attend study visits at 12 weeks and 6 months * complete questionnaires on daily functioning, pain, and quality of life * undergo CT scans and other medical assessments * record collar use (for conservative group) in a diary * be monitored for any complications or changes in treatment (including crossover to surgery if needed) The study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.
Key facts
- Study ID
- NCT06961578
- Run by
- Technical University of Munich
- People needed
- 322
- Starts
- 2025-08-13
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Charité University Hospital Berlin — Berlin, State of Berlin, Germany (enrolling)
- Department of Neurosurgery, University Hospital of Lausitz — Lausitz, Germany (enrolling)
- Department of Neurosurgery, RWTH Aachen University — Aachen, Germany
- Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin Buch — Berlin, Germany
- Department of Orthopaedic and Traumatology, University of Cologne — Cologne, Germany
- Department of Orthopedics, Medical University at Dresden — Dresden, Germany
- Department of Neurosurgery and Spine Surgery, University Hospital Essen — Essen, Germany
- Department of Neurosurgery, University Medical Center Göttingen — Göttingen, Germany
- Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost Halle — Halle, Germany
- Department of Neurosurgery, University Hospital Heidelberg — Heidelberg, Germany
- Department of Orthopaedics, Trauma Surgery and Plastic Surgery, University of Leipzig — Leipzig, Germany
- Spine Surgery, Orthopedic Hospital Markgröningen GmbH — Markgröningen, Germany
- BG Trauma Centre, Eberhard Karls University of Tuebingen — Tübingen, Germany
- LMU University Hospital — Munich, Bavaria, Germany
- Spine Center, St. Josefs-Hospital Wiesbaden — Wiesbaden, Germany
- Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik — Frankfurt am Main, Hesse, Germany
Full record on ClinicalTrials.gov
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