RecruitingNot ApplicableNCT06961578

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

Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)


Sponsor

Technical University of Munich

Enrollment

322 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 70 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

PROCEDUREC1-2 instrumentation

Surgical fracture stabilization with a posterior screw-rod system from C1-2 from a posterior approach. The routine surgery commonly lasts approximately 100 minutes and requires a hospital stay of about 6 days. An additional external bracing in the postoperative setting is not required.

OTHERExternal immobilization with rigid cervical collar

External immobilization with a rigid cervical collar for 12 weeks. Compliance is monitored through patient diaries, recognizing the real-world challenges of consistent brace use. Lack of adherence is considered to reflect routine clinical practice. A typical drawback of the conservative intervention in daily practice is the absolute reliance on patient compliance to wear the collar continuously for at least 12 weeks, which poses a significant challenge to this treatment strategy.


Locations(16)

LMU University Hospital

Munich, Bavaria, Germany

Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik

Frankfurt am Main, Hesse, Germany

Charité University Hospital Berlin

Berlin, State of Berlin, Germany

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 Neurosurgery, University Hospital of Lausitz

Lausitz, 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

Spine Center, St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

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NCT06961578


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