Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT06961578

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

Led by Technical University of Munich · Updated on 2026-05-06

322

Participants Needed

16

Research Sites

146 weeks

Total Duration

On this page

Sponsors

T

Technical University of Munich

Lead Sponsor

S

St. Josefs-Hospital Wiesbaden GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 70 years old
  • Acute unstable odontoid fractures (types II, III, and atypical)
  • Injury occurred less than two weeks ago
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment for odontoid fracture
  • Other fractures of the lower cervical spine requiring surgery
  • Serious health issues making surgery unsafe (ASA score greater than 4)
  • Neurological problems caused by displaced fracture

AI-Screening

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Trial Site Locations

Total: 16 locations

1

LMU University Hospital

Munich, Bavaria, Germany, 81377

Not Yet Recruiting

2

Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik

Frankfurt am Main, Hesse, Germany, 60389

Not Yet Recruiting

3

Charité University Hospital Berlin

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

4

Department of Neurosurgery, RWTH Aachen University

Aachen, Germany

Not Yet Recruiting

5

Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin Buch

Berlin, Germany

Not Yet Recruiting

6

Department of Orthopaedic and Traumatology, University of Cologne

Cologne, Germany

Not Yet Recruiting

7

Department of Orthopedics, Medical University at Dresden

Dresden, Germany

Not Yet Recruiting

8

Department of Neurosurgery and Spine Surgery, University Hospital Essen

Essen, Germany

Not Yet Recruiting

9

Department of Neurosurgery, University Medical Center Göttingen

Göttingen, Germany

Not Yet Recruiting

10

Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost Halle

Halle, Germany

Not Yet Recruiting

11

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, Germany

Not Yet Recruiting

12

Department of Neurosurgery, University Hospital of Lausitz

Lausitz, Germany

Actively Recruiting

13

Department of Orthopaedics, Trauma Surgery and Plastic Surgery, University of Leipzig

Leipzig, Germany

Not Yet Recruiting

14

Spine Surgery, Orthopedic Hospital Markgröningen GmbH

Markgröningen, Germany

Not Yet Recruiting

15

BG Trauma Centre, Eberhard Karls University of Tuebingen

Tübingen, Germany

Not Yet Recruiting

16

Spine Center, St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

Not Yet Recruiting

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Research Team

M

Maria Wostrack, Prof. Dr.

CONTACT

A

Arthur Wagner, PD Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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