SCORE Trial: Comparing Surgical vs. Conservative Treatment for Odontoid Fractures in Elderly Patients

The SCORE study is a groundbreaking multicenter randomized controlled trial investigating whether conservative treatment with a rigid cervical collar is non-inferior to surgical stabilization for odontoid fractures (OFs) in patients aged 70 or older. This open-label parallel-group study aims to revolutionize treatment approaches for this vulnerable population by providing high-quality evidence on functional recovery and quality of life outcomes.

Primary Objective: The trial will compare the effectiveness of surgical versus conservative treatment in restoring daily functioning, measured by changes in the Barthel Index (BI) from baseline to 12 weeks post-treatment.

Key Secondary Outcomes: The study will also evaluate:

• Quality of life improvements using EQ-5D
• Neck pain reduction via Visual Analog Scale
• Neck-specific disability through Neck Disability Index
• Fracture healing rates via radiographic assessment
• Treatment compliance and crossover rates
• Safety profiles of both approaches

Study Design: With 322 participants anticipated across multiple German centers, patients will be randomly assigned to either:

• Surgical group: Receiving posterior C1-C2 screw-rod fixation (approximately 100-minute procedure with 6-day hospitalization)
• Conservative group: Wearing a rigid cervical collar for 12 weeks with compliance monitoring

The trial employs rigorous methodology including stratified randomization, mixed model statistical analysis, and oversight by an independent Data and Safety Monitoring Board. A non-inferiority margin of 5 BI points has been established based on extensive clinical research.

Clinical Significance: This study addresses a critical knowledge gap in geriatric spine trauma care. Odontoid fractures in the elderly present unique challenges, and current treatment approaches vary considerably. The SCORE trial results could significantly impact clinical practice by either validating conservative management or confirming the superiority of surgical intervention for this high-risk population.

Follow-up assessments at 12 weeks and 6 months will provide comprehensive data on both short-term recovery and longer-term outcomes. The study's innovative design allows for crossover from conservative to surgical treatment within the first 12 weeks when clinically indicated, reflecting real-world practice while maintaining scientific rigor.