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临床试验/CTRI/2025/12/099846
CTRI/2025/12/099846尚未招募不适用

Evaluation of Clinical Outcomes of Preserving Versus Sacrificing C2 and C7 Spinous Process Attachments in Patients Undergoing Cervical Laminectomy: A Retrospective Observational Study

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. mJOA score for neurological outcome

研究概览

简要总结

This retrospective observational study will be conducted in Stavya Spine Hospital and Research Institute, Ahmedabad enrolling 100 consecutive patients diagnosed with multilevel cervical stenosis and myelopathy requiring C3-C6 or C3-C7 laminectomy. Patients will be randomly allocated into two equal groups: Group A and Group B. Group A (n=50) underwent modified muscle-preserving laminectomy with preservation of semispinalis cervicis and nuchal ligament attachments at C2 and C7 spinous processes, while Group B (n=50) underwent conventional laminectomy with complete detachment of posterior muscle complex from C2 and C7. The study will include patients of 40-75 years of age with multilevel cervical stenosis (Greater or equal to 3 levels), preoperative modified Japanese Orthopedic Association (mJOA) scores of 8-14, and minimum 6 month follow up. Patients with previous cervical surgery, congenital anomalies, inflammatory arthropathies, cervical trauma, malignancy and patients with incomplete clinical and radiological records will be excluded from the study.

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
All

入选标准

  • •More than or equal to 3 levels of cervical spinal stenosis and myelopathy
  • •Preoperative and postoperative imaging available (MRI, CT, or X-rays).

排除标准

  • •A documented history of prior cervical spine surgery Presence of congenital anomalies Inflammatory arthropathies History of cervical trauma History of histologically proven cervical spinal tumor Patients with less than 6 months follow up post operatively Patients with incomplete pre operative or post operative data.

结局指标

主要结局

1. mJOA score for neurological outcome

时间窗: Follow up visits at 3 months and 6 months

2. NDI score for functional disability

时间窗: Follow up visits at 3 months and 6 months

3. VAS score for pain

时间窗: Follow up visits at 3 months and 6 months

4. Operative parameters which included intra operative blood loss, operative time and post op complications

时间窗: Follow up visits at 3 months and 6 months

次要结局

  • NIL.(NIL.)

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

研究点 (1)

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