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

NANot yet recruitingINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 12, 2027

Study Completion Date

June 1, 2028

Conditions
Odontoid FractureElderly
Interventions
PROCEDURE

C1-2 instrumentation

"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."

OTHER

External immobilization with rigid cervical collar

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.

Trial Locations (16)

10117

Charité University Hospital Berlin, Berlin

60389

Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main

81377

LMU University Hospital, Munich

Unknown

Department of Neurosurgery, RWTH Aachen University, Aachen

Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin Buch, Berlin

Department of Orthopaedic and Traumatology, University of Cologne, Cologne

Department of Orthopedics, Medical University at Dresden, Dresden

Department of Neurosurgery and Spine Surgery, University Hospital Essen, Essen

Department of Neurosurgery, University Medical Center Göttingen, Göttingen

Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost Halle, Halle

Department of Neurosurgery, University Hospital Heidelberg, Heidelberg

Department of Neurosurgery, University Hospital of Lausitz, Lausitz

Department of Orthopaedics, Trauma Surgery and Plastic Surgery, University of Leipzig, Leipzig

Spine Surgery, Orthopedic Hospital Markgröningen GmbH, Markgröningen

BG Trauma Centre, Eberhard Karls University of Tuebingen, Tübingen

Spine Center, St. Josefs-Hospital Wiesbaden, Wiesbaden

All Listed Sponsors
collaborator

St. Josefs-Hospital Wiesbaden GmbH

OTHER

collaborator

Medical University of Cologne

OTHER

collaborator

BG Trauma Center Tuebingen

OTHER

collaborator

RWTH Aachen University

OTHER

collaborator

University Hospital Heidelberg

OTHER

collaborator

University Hospital, Essen

OTHER

collaborator

BG Klinikum Bergmannstrost, Halle, Germany

UNKNOWN

collaborator

Helios Klinikum Berlin-Buch

OTHER

collaborator

German Federal Ministry of Education and Research

OTHER_GOV

collaborator

Charite University, Berlin, Germany

OTHER

lead

Technical University of Munich

OTHER