SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorTechnical University of Munich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 70 years old
Acute unstable OFs (types II, III as classified by Anderson and d'Alonzo, and atypical)
Less than two weeks post injury
Written informed consent
Disqualifiers
Previous treatment for odontoid fracture
Concomitant fractures of the subaxial cervical spine necessitating surgery
Significant comorbidity resulting in inoperability of the patient: i.e. ASA score > 4
Neurological compromise due to displaced fracture
Trial design
Design model
Parallel
Treatments tested in this trial
C1-2 instrumentation
Procedure/SurgerySurgical 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.
External immobilization with rigid cervical collar
Other interventionExternal 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.
Treatment groups
322 Participants
are divided into 2 treatment groupsGroup A: Conservative GroupExperimental treatment 1 intervention
Group B: Surgical GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Barthel Index
Change in Barthel Index (BI) between baseline and 12 weeks thereafter
Time frame
Baseline to 12 weeksSecondary outcomes
1
Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D)
Change in quality of life assessed by the EQ-5D between baseline, 12 weeks and 6 months. Minimum score 0, Maximum score 100, higher scores denote higher perceived quality of life.
Time frame
Baseline to 12 weeks and to 6 months.2
Duration of surgery
Duration of surgery for the surgery/intervention group.
Time frame
Baseline value (time of surgery)3
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Time frame
Baseline to 12 weeks4
Neck-Disability-Index (NDI)
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Time frame
Baseline, 12 weeks and 6 months after surgery/interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Technical University of Munich
Lead sponsor
St. Josefs-Hospital Wiesbaden GmbH
Collaborator
Medical University of Cologne
Collaborator
BG Trauma Center Tuebingen
Collaborator
RWTH Aachen University
Collaborator
University Hospital Heidelberg
Collaborator
University Hospital, Essen
Collaborator
BG Klinikum Bergmannstrost, Halle, Germany
Collaborator
Helios Klinikum Berlin-Buch
Collaborator
German Federal Ministry of Education and Research
Collaborator
Charite University, Berlin, Germany
Collaborator
Source ClinicalTrials.gov