Trial reportPloS one2025
Surgical versus conservative treatment of odontoid fractures in the elderly: A randomized controlled clinical study (SCORE).
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06961578 (Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
39 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOdontoid fractures of the second cervical vertebra commonly affect elderly patients due to osteoporosis and low-energy trauma. Treatment is controversial, with prolonged cervical collar immobilization risking non-union and complications, and surgical C1-C2 stabilization involving higher upfront surgical risks. High-level evidence from randomized controlled trials to guide optimal treatment decisions is lacking. The SCORE study aims to determine whether surgical stabilization is non-inferior to conservative collar management in maintaining functional independence for elderly patients with unstable odontoid fractures.
methodsSCORE is a multicenter, parallel-group, randomized controlled non-inferiority trial enrolling 322 patients aged ≥70 years with acute (≤2 weeks) unstable odontoid Type II, III, or atypical fractures. Participants will be randomized 1:1, stratified by center, to receive surgical stabilization via posterior C1-C2 fixation or conservative management with a rigid cervical collar. The primary outcome measure is the change in Barthel Index (BI) from baseline to 12 weeks. Secondary outcomes include quality of life (EQ-5D), neck pain (Visual Analog Scale, VAS), neck disability (Neck Disability Index, NDI), radiographic fusion, treatment compliance, cross-over rates to surgery, and incidence of adverse and serious adverse events up to 6 months. Follow-ups will take place at 12 weeks and 6 months post-injury, with an additional visit at approximately 2 weeks post-surgery for surgical patients. Analysis will use mixed models for repeated measures, targeting 90% power to detect non-inferiority within a 5-point margin on the BI (one-sided α = 0.025), accounting for 15% attrition. DISCUSSION: This trial addresses a critical evidence gap by directly comparing surgical and conservative treatments, aiming to guide clinical decision-making and improve functional outcomes and quality of life in elderly patients.
trial registrationClinicalTrials.gov, ID: NCT06961578.
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