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)
2 other identifiers
interventional
322
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
August 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 6, 2026
May 1, 2025
2.3 years
April 20, 2025
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Barthel Index
Change in Barthel Index (BI) between baseline and 12 weeks thereafter
Baseline to 12 weeks
Secondary Outcomes (9)
Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D)
Baseline to 12 weeks and to 6 months.
Duration of surgery
Baseline value (time of surgery)
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Baseline to 12 weeks
Neck-Disability-Index (NDI)
Baseline, 12 weeks and 6 months after surgery/intervention
Charlson Comorbidity Index (CCI)
Baseline value
- +4 more secondary outcomes
Study Arms (2)
Conservative Group
EXPERIMENTALconservative group subjected to external collar bracing
Surgical Group
EXPERIMENTALsurgical group undergoing C1-2 instrumentation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Federal Ministry of Education and Researchcollaborator
- Technical University of Munichlead
- St. Josefs-Hospital Wiesbaden GmbHcollaborator
- Medical University of Colognecollaborator
- BG Trauma Center Tuebingencollaborator
- RWTH Aachen Universitycollaborator
- University Hospital Heidelbergcollaborator
- University Hospital, Essencollaborator
- BG Klinikum Bergmannstrost, Halle, Germanycollaborator
- Helios Klinikum Berlin-Buchcollaborator
- Charite University, Berlin, Germanycollaborator
Study Sites (16)
LMU University Hospital
Munich, Bavaria, 81377, Germany
Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik
Frankfurt am Main, Hesse, 60389, Germany
Charité University Hospital Berlin
Berlin, State of Berlin, 10117, 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
Related Publications (1)
Wagner A, Albrecht C, Dittmer S, Egert-Schwender S, Kehl V, Stichling R, Klatt G, Ettinger B, Hecht N, Vajkoczy P, Wengert A, Kandziora F, von der Hoh NH, Heyde CE, Hartung P, Richter M, Lenz M, Eysel P, Badke A, Blume C, Clusmann H, Walter J, Krieg S, Evangelou P, Shiban E, Dreimann M, Gembruch O, Sure U, Bettag C, Rohde V, Disch A, Bekele B, Ryang YM, Kramer A, Ringel F, Wach J, Guresir E, Meyer B, Wostrack M. Surgical versus conservative treatment of odontoid fractures in the elderly: A randomized controlled clinical study (SCORE). PLoS One. 2025 Dec 23;20(12):e0337999. doi: 10.1371/journal.pone.0337999. eCollection 2025.
PMID: 41433244DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2025
First Posted
May 8, 2025
Study Start
August 13, 2025
Primary Completion (Estimated)
December 12, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
May 6, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share