Surgical versus conservative treatment of odontoid fractures in the elderly: a randomized controlled clinical study (SCORE)
Background Odontoid 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 u...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
December 23, 2025
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| In: |
PLOS ONE
Year: 2025, Volume: 20, Issue: 12, Pages: 1-14 |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0337999 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1371/journal.pone.0337999 Verlag, kostenfrei, Volltext: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0337999 |
| Author Notes: | Arthur Wagner, Carolin Albrecht, Sophie Dittmer, Silvia Egert-Schwender, Victoria Kehl, Rita Stichling, Gisela Klatt, Barbara Ettinger, Nils Hecht, Peter Vajkoczy, Alexander Wengert, Frank Kandziora, Nicolas Heinz von der Höh, Christoph-Eckhard Heyde, Philipp Hartung, Marcus Richter, Maximilian Lenz, Peer Eysel, Andreas Badke, Christian Blume, Hans Clusmann, Johannes Walter, Sandro Krieg, Petros Evangelou, Ehab Shiban, Marc Dreimann, Oliver Gembruch, Ulrich Sure, Christoph Bettag, Veit Rohde, Alexander Disch, Biniam Bekele, Yu-Mi Ryang, Andreas Kramer, Florian Ringel, Johannes Wach, Erdem Güresir, Bernhard Meyer, Maria Wostrack |
| Summary: | Background Odontoid 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. Methods SCORE 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. |
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| Item Description: | Gesehen am 02.04.2026 |
| Physical Description: | Online Resource |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0337999 |