Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 322
- 试验地点
- 32
- 主要终点
- Barthel Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conservative Group
conservative group subjected to external collar bracing
干预措施: External immobilization with rigid cervical collar (Other)
Surgical Group
surgical group undergoing C1-2 instrumentation
干预措施: C1-2 instrumentation (Procedure)
结局指标
主要结局
Barthel Index
时间窗: Baseline to 12 weeks
Change in Barthel Index (BI) between baseline and 12 weeks thereafter
次要结局
- Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D)(Baseline to 12 weeks and to 6 months.)
- Duration of surgery(Baseline value (time of surgery))
- Duration of time per day the cervical collar is worn (patient/proxy protocol)(Baseline to 12 weeks)
- Neck-Disability-Index (NDI)(Baseline, 12 weeks and 6 months after surgery/intervention)
- Charlson Comorbidity Index (CCI)(Baseline value)
- Union rate of fracture(12 weeks after surgery/intervention)
- Readmission to hospital(Baseline to 12 weeks to 6 months)
- Cross-over rate(Baseline to 12 weeks)
- Change in Visual Analogue Scale Pain (VAS)(baseline, immediately after surgery/intervention, 12 weeks after surgery/intervention and 6 months after surgery/intervention)