NCT06961578 SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
| NCT ID | NCT06961578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | Odontoid Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 322 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2027-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 322 participants in total. It began in 2025-08-13 with a primary completion date of 2027-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06961578 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Odontoid Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06961578 currently recruiting?
Yes, NCT06961578 is actively recruiting participants. Contact the research team at Maria.wostrack@tum.de for enrollment information.
Where is the NCT06961578 trial being conducted?
This trial is being conducted at Munich, Germany, Frankfurt am Main, Germany, Berlin, Germany, Aachen, Germany and 11 additional locations.
Who is sponsoring the NCT06961578 clinical trial?
NCT06961578 is sponsored by Technical University of Munich. The trial plans to enroll 322 participants.