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Search / Trial NCT06961578

SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70

Launched by TECHNICAL UNIVERSITY OF MUNICH · May 5, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Odontoid Fracture C2 Fracture Atlantoaxial Instability Atlantoaxial Fusion Barthel Index Functional Outcome

ClinConnect Summary

The SCORE Study is a clinical trial designed to compare two different treatments for unstable neck fractures, known as odontoid fractures, in adults aged 70 and older. These fractures can greatly affect a person's ability to move and live independently. The study aims to find out if surgery or wearing a rigid collar leads to better improvements in daily activities, pain levels, and overall quality of life after 12 weeks of treatment. By enrolling 322 participants, the researchers hope to determine which approach helps older adults recover more effectively with fewer complications.

To be eligible for the study, participants must be at least 70 years old and have suffered an acute unstable odontoid fracture within the last two weeks. Those who join the trial will be randomly assigned to either receive surgery or wear a collar. They will attend follow-up visits at 12 weeks and 6 months, complete questionnaires about their daily functioning and pain, and undergo medical assessments, including CT scans. Participants in the collar group will also keep a diary to track their collar use. The study is not yet recruiting, but it is an important step toward finding the best treatment for older adults with these types of fractures.

Gender

ALL

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

About Technical University Of Munich

The Technical University of Munich (TUM) is a leading research institution in Germany, renowned for its commitment to excellence in education, innovation, and technology transfer. With a strong emphasis on interdisciplinary collaboration, TUM fosters advancements in various fields, including medicine and life sciences. The university actively engages in clinical research, aiming to translate scientific discoveries into practical applications that improve patient outcomes. Through its state-of-the-art facilities and a network of partnerships with hospitals and industry, TUM is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards and contribute significantly to the advancement of healthcare.

Locations

Munich, Bavaria, Germany

Frankfurt Am Main, Hessen, Germany

Aachen, , Germany

Berlin, , Germany

Berlin, , Germany

Cologne, , Germany

Dresden, , Germany

Essen, , Germany

Göttingen, , Germany

Halle, , Germany

Heidelberg, , Germany

Lausitz, , Germany

Leipzig, , Germany

Markgröningen, , Germany

Tuebingen, , Germany

Wiesbaden, , Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported