Does Preservation of C2 and C7 Spinous Process Attachments Improve Patient Outcomes in Cervical Laminectomy? A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- mJOA scores (0-18): Assessed preoperatively and at 3, 6, 12, and 24 months postoperatively. JOA recovery rate calculated using: Recovery Rate (%) = [(Postoperative JOA - Preoperative JOA) / (17 - Preoperative JOA)] × 100.
研究概览
简要总结
This prospective observational comparative study will be conducted at Stavya Spine Hospital and Research Institute, Ahmedabad. The study enrolled 200 consecutive patients diagnosed with multilevel cervical spondylotic myelopathy (CSM) requiring cervical laminectomy at C3-C6 or C3-C7 levels. Patients will be prospectively distributed into two equal groups based on the surgical technique employed at the time of surgery: Group A (Preservation Group, n=100) which will undergo modified muscle-preserving laminectomy with preservation of semispinalis cervicis and nuchal ligament attachments at C2 and C7 spinous processes, while Group B (Conventional Group, n=100) will undergo conventional laminectomy with complete detachment of the posterior muscle complex from C2 and C7 spinous processes. Written informed consent was obtained from all participants prior to surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Multilevel cervical stenosis involving greater or equal to 3 consecutive levels
- •Symptomatic cervical myelopathy with clinical and radiological correlation.
排除标准
- •Documented history of prior cervical spine surgery.
- •Congenital spinal anomalies.
- •Individuals with inflammatory arthropathies.
- •Individuals with a history of traumatic injury to the cervical spine.
- •Individuals with significant comorbidities that may interfere with treatment outcomes (e.g., severe osteoporosis, malignancies, or systemic inflammatory disorders).
- •Ossification of Posterior Longitudinal Ligament (OPLL) extending beyond C2 and/or C
- •Inability to comply with the follow up schedule.
- •Pathology extending beyond C2 and/or C7.
结局指标
主要结局
mJOA scores (0-18): Assessed preoperatively and at 3, 6, 12, and 24 months postoperatively. JOA recovery rate calculated using: Recovery Rate (%) = [(Postoperative JOA - Preoperative JOA) / (17 - Preoperative JOA)] × 100.
时间窗: Follow up visits at 3 months, 6 months and 1 year
Visual Analogue Scale (VAS) for axial neck pain : Measured at all time points, with 0 indicating no pain and 10 indicating worst imaginable pain.
时间窗: Follow up visits at 3 months, 6 months and 1 year
Neck Disability Index (NDI) (0-50 scale or percentage): Assessed at all time points, evaluating functional disability related to neck pain.
时间窗: Follow up visits at 3 months, 6 months and 1 year
Cervical Range of Motion (ROM) (degrees): Measured on dynamic lateral radiographs at 12 postoperatively.
时间窗: Follow up visits at 3 months, 6 months and 1 year
次要结局
- C2-C7 Cobb angle (degrees): Measured on lateral cervical radiographs at preoperative baseline & 12 months postoperatively.(C2-C7 sagittal vertical axis (SVA) (mm): Measured on lateral cervical radiographs at baseline & 12 months.)
研究者
Dr Bharat R Dave
Stavya Spine Hospital And Research Institute