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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorTechnical University of Munich

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • C1-2 instrumentation
  • External immobilization with rigid cervical collar

Treatment groups

322 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Technical University of Munich

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Collaborator

Medical University of Cologne

Collaborator

BG Trauma Center Tuebingen

Collaborator

RWTH Aachen University

Collaborator

University Hospital Heidelberg

Collaborator

University Hospital, Essen

Collaborator

BG Klinikum Bergmannstrost, Halle, Germany

Collaborator

Helios Klinikum Berlin-Buch

Collaborator

German Federal Ministry of Education and Research

Collaborator

Charite University, Berlin, Germany

Collaborator