SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C1-2 instrumentation, External immobilization with rigid cervical collar.
- Who it may be relevant to
- Registry conditions: Odontoid Fracture, Elderly. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
Overview
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.
Detailed description
The SCORE study is a multicenter, randomized, controlled, open-label, parallel-group non-inferiority trial designed to provide evidence on whether conservative treatment is non-inferior to surgical stabilization regarding recovery of daily functioning.
Study Objectives A) Primary Objective: To compare the effectiveness of surgical versus conservative treatment for unstable OFs in patients aged 70 or older in terms of recovery in activities of daily living, measured by the change in Barthel Index (BI) from baseline to 12 weeks.
B) Secondary Objectives: To compare the effects of treatment on:
* Quality of life (EQ-5D) * Neck pain (Visual Analog Scale) * Neck-specific disability (Neck Disability Index) * Radiographic fracture healing * Treatment compliance * Rate of crossover from conservative to surgical treatment * Incidence of adverse and serious adverse events
This is a prospective, two-arm, multicenter, randomized controlled non-inferiority trial with parallel-group design. Patients will be randomized 1:1 to receive either surgical stabilization (posterior C1-C2 screw-rod fixation) or conservative treatment with a rigid cervical collar. Randomization will be stratified by center using permuted blocks via the secure online platform randomizer.at. Participants are followed up at 12 weeks and 6 months post-injury. An additional visit \~2 weeks after surgery is conducted for those undergoing surgical treatment. Patients in the conservative arm may cross over to surgery up to week 12, based on clinical indication or patient preference.
Intervention Descriptions A) Surgical Group: Posterior stabilization using a screw-rod system without additional external bracing. The surgery lasts \~100 minutes and requires \~6 days of hospital stay. This approach is tailored for geriatric patients and excludes anterior fixation due to biomechanical concerns in the elderly.
B) Conservative Group: External immobilization using a rigid cervical collar for 12 weeks. Compliance is monitored via patient diaries, acknowledging real-world challenges in consistent brace use. Lack of adherence is considered reflective of routine clinical practice.
Statistical Analyses The primary analysis will assess non-inferiority of conservative treatment versus surgery using a mixed model for repeated measures (MMRM) of the BI at 12 weeks. Covariates include treatment, time, interaction terms, baseline BI, age, and CCI; study center is treated as a random effect (excluded if convergence fails). Non-inferiority is defined by a margin of 5 BI points, which is more conservative than the minimal clinically important difference (MCID) of 9.8 and closer to the smallest detectable change (SDC) of 3.0, based on prior studies. The study has 90% power to detect non-inferiority (one-sided α = 0.025). A total of 137 patients per arm (274 total) are needed, inflated to 322 to account for 15% attrition.
Secondary analyses will use similar mixed models for continuous variables and generalized estimating equations for binary outcomes. Sensitivity analyses include "as-treated" models accounting for crossover. No adjustment for multiple comparisons will be made.
Randomization Procedure Randomization is conducted after informed consent via randomizer.at. Lists are stratified by center and use permuted blocks. Access is password-protected and managed by study personnel.
An independent Data and Safety Monitoring Board (DSMB) will oversee the study. All adverse events and serious adverse events are recorded at each visit and coded per MedDRA prior to analysis.
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.
Primary outcome measures
- Barthel Index [Time frame: Baseline to 12 weeks]
Secondary outcome measures (9)
- Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D) [Time frame: Baseline to 12 weeks and to 6 months.]
- Duration of surgery [Time frame: Baseline value (time of surgery)]
- Duration of time per day the cervical collar is worn (patient/proxy protocol) [Time frame: Baseline to 12 weeks]
- Neck-Disability-Index (NDI) [Time frame: Baseline, 12 weeks and 6 months after surgery/intervention]
- Charlson Comorbidity Index (CCI) [Time frame: Baseline value]
- Union rate of fracture [Time frame: 12 weeks after surgery/intervention]
- Readmission to hospital [Time frame: Baseline to 12 weeks to 6 months]
- Cross-over rate [Time frame: Baseline to 12 weeks]
- Change in Visual Analogue Scale Pain (VAS) [Time frame: baseline, immediately after surgery/intervention, 12 weeks after surgery/intervention and 6 months after surgery/intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 16 centers
- LMU University Hospital — Munich
- Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik — Frankfurt am Main
- Charité University Hospital Berlin — Berlin
- 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
- … and 8 more centers
Publications
- Wagner A, Albrecht C, Dittmer S, Egert-Schwender S, Kehl V, Stichling R, Klatt G, Ettinger B, Hecht N, Vajkoczy P, Wengert A, Kandziora F, von der Hoh NH, Heyde CE, Hartung P, Richter M, Lenz M, Eysel P, Badke A, Blume C, Clusmann H, Walter J, Krieg S, Evangelou P, Shiban E, Dreimann M, Gembruch O, Sure U, Bettag C, Rohde V, Disch A, Bekele B, Ryang YM, Kramer A, Ringel F, Wach J, Guresir E, Meyer PMID 41433244
Identifiers
NCT: NCT06961578 · 2024-630-S-NP · 01KG2405