NCT06961578

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

Not yet recruiting NA Last updated 8 May 2025

What this trial tests

NA trial testing C1-2 instrumentation in Odontoid Fracture in 322 participants. Not yet recruiting.

Timeline

1 June 2025

Primary endpoint
12 December 2027

1 June 2028

Quick facts

Lead sponsor	Technical University of Munich
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	322
Start date	1 June 2025
Primary completion	12 December 2027
Estimated completion	1 June 2028
Sites	16 locations across Germany

Drugs / interventions tested

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

Conditions studied

• Odontoid Fracture — all drugs for Odontoid Fracture →
• Elderly — all drugs for Elderly →

Sponsor

Technical University of Munich

Who can join

70 and older, any sex, with Odontoid Fracture or Elderly. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Surgical versus conservative treatment of odontoid fractures in the elderly: A randomized controlled clinical study (SCORE).
   Wagner A, Albrecht C, Dittmer S, Egert-Schwender S, et al · · 2025 · PMID 41433244 · DOI 10.1371/journal.pone.0337999