Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- neck disability
研究概览
简要总结
This prospective study addresses one of the most controversial topics in the treatment of cervical spine trauma: the management of type II odontoid process fractures in the elderly. It is the hypothesis that surgical treatment will result in improved functional outcome measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore, it is hypothesized that surgical treatment of odontoid process fractures will limit hospital re-admissions and development of medical complications secondary to prolonged immobilization in a cervical orthosis and delayed surgery related to late fracture displacement, which are often associated with non-operative care. Additionally, data from this study will be useful in identifying patient-specific predictors of improved outcome which can be used to optimize treatment algorithms and more effectively counsel patients who sustain these injuries.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be considered for trial enrollment will include those:
- •ages 65 and older;
- •presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
- •deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
- •able to independently cooperate in the completion of all study consents, forms and documents.
- •able to speak, read and write English at an elementary school level
排除标准
- •Patients to be excluded from trial enrolment include:
- •those with previously documented type II odontoid fracture;
- •those with odontoid fracture related to malignancy or infection;
- •those with associated spinal cord injury
- •those with other cervical, thoracic or lumbar injuries requiring surgical intervention
- •those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation
研究组 & 干预措施
post-injury bracing with rigid cervical collar
Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
干预措施: Bracing (Procedure)
posterior C1-2 instrumented fusion
Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
干预措施: posterior C1-C2 instrumented fusion (Procedure)
结局指标
主要结局
neck disability
时间窗: 6 months post randomization
Measured by validated outcome measure NDI (Neck Disability Index)
次要结局
未报告次要终点