Actively Recruiting
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
Eligibility Criteria
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
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
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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