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.
