Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 269
- 试验地点
- 2
- 主要终点
- Total Health Costs - Societal Perspective
研究概览
简要总结
The purpose of the study is to determine the cost-effectiveness of different surgical strategies to treat cervical spondylotic myelopathy. The study will use data generated from the CSM-S Trial (NCT02076113).
- To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.
- To determine the relative cost-effectiveness between anterior cervical discectomy and fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.
详细描述
In this study, the investigators aim to cover a significant gap in the literature, namely, to compare anterior and posterior surgical approaches for the management of CSM on the cost of care. The investigators will conduct a post-hoc analysis of data from the randomized trial "Cervical Spondylotic Myelopathy Surgical Trial" (www.ClinicalTrials.gov; identifier: NCT02076113). This trial was conducted in collaboration between multiple academic institutions in North America. The results of the CSM-S RCT in terms of clinical and patient-reported outcomes suggested similar effectiveness with anterior and posterior surgical approaches. Notably, the study showed that cervical laminoplasty, a relatively low instrumentation-related cost procedure, was effective in managing CSM. The findings of the analysis proposed herein will add a new dimension to clinical decision-making by informing patient selection and improving the quality of care.
Post-hoc analysis will be conducted on the following data that were collected during the trial.
I. Functional outcomes determined by well-known quantitative scales (SF-36, Oswestry Neck, mJOA, and EuroQol-5D) at pre-op, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years.
II. Health resource utilization information was collected using patient diaries along with copies of all medical bills and receipts at 1 month, 3 months, 6 months, and 12 months post-operatively for all patients. Participants were asked to monitor days missed from work and days unable to perform usual activities, in addition to days missed from work for medical treatments or evaluations.
The overall cost will be estimated for each patient from a societal perspective and will include the following components:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Cervical Myelopathy (> or equal to 2 levels of spinal cord compression from C3 to C7) with 2 or more of the following symptoms/ signs: clumsy hands, gait disturbance, hyperreflexia, upgoing toes, bladder dysfunction.
排除标准
- •C2-C7 kyphosis>5 degrees (measured in standing extension radiograph)
- •segmental kyphotic deformity (defined by greater than 3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT)
- •structurally significant ossification of the posterior longitudinal ligament (OPLL - measured on cervical spine CT)
- •previous cervical spine surgery, or significant active health-related co-morbidity (Anesthesia Class IV or higher)
结局指标
主要结局
Total Health Costs - Societal Perspective
时间窗: 5 years
Index hospitalization costs+one-year all cause costs+loss of productivity costs
次要结局
- Index Hospitalization Costs(30 days)
- Loss of productivity costs(5 years)
- 1-Year all-cause health costs(1 year)