Cervical Spondylotic Myelopathy Surgical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Lahey Clinic
- 入组人数
- 269
- 试验地点
- 16
- 主要终点
- Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
研究概览
简要总结
The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world.
This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.
详细描述
Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism.
If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty).
Treatment A: Decompression/fusion from the front of the neck.
Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below):
Dorsal decompression/fusion or dorsal laminoplasty (no fusion)
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CSM (≥2 levels of spinal cord compression from C3 to C7)
- •Present with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction.
排除标准
- •C2-C7 kyphosis>5º (measured in standing neutral cervical spine radiograph),
- •Segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT),
- •Structurally significant ossification of posterior longitudinal ligament (OPLL - measured on cervical spine CT),
- •Previous cervical spine surgery
- •Significant active health-related co-morbidity (Anesthesia Class IV or higher).
研究组 & 干预措施
Dorsal
Dorsal Decompression with Fusion or Dorsal Laminoplasty
干预措施: Dorsal (back) Laminoplasty (Procedure)
Ventral
Ventral Decompression with Fusion
干预措施: Ventral (Front) decompression with Fusion (Procedure)
Dorsal
Dorsal Decompression with Fusion or Dorsal Laminoplasty
干预措施: Dorsal (Back) Decompression with Fusion (Procedure)
结局指标
主要结局
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
时间窗: 1 year and 2 year
Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life.
次要结局
- Short Form-36 (SF-36) Physical Component Summary (PCS) Score(Pre-operative, 1 year and 2 year)
- Oswestry Neck Disability Index (NDI)(Pre-operative, 1 year and 2 year)
- EuroQol-5D(Pre-operative, 1 year and 2 year)
- Modified Japanese Orthopedic Association Score mJOA(Pre-operative and 1 year)
- Sagittal Balance Measurements(1 year)
- Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty(Within 1 year of surgery)
- Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty(Pre-operative, 1, 3 and 6 months and 1 year)
- Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months(3 months, 1 year)
- Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty(Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.)