Comparison of anterior cervical fusion using Grafton ® vs local bone graft in Divergence ® interbody cage for cervical degenerative diseases - Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Fusion
研究概览
简要总结
This academic study will be done at Sakra World Hospital. The patients (56) with degenerative cervical diseases and who fulfill the selection criteria will be randomized and will be grouped into Group A (28) - Grafton and Group B (28) - bone graft group. Both groups will be operated with Anterior cervical fusion surgeries with Divergence cage and the cage will be filled with Grafton - DBM in A group and local bone graft in B group. They will be analyzed and compared at 0,3,6,12 months both clinically and radiologically (Xray and CT). The clinical parameters that will be analyzed are m-JOA, VAS score for neck and radicular pain, Nuricks, Odoms criteria, and NDI. Radiologically they will be analyzed for fusion status and the time taken for fusion. The outcomes will be analyzed, compared and appropriate statistics will be applied for the interpretation of results
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Degenerative disease of the cervical spine and •Radiculopathy •Myelopathy •Kyphosis and disability.
排除标准
- •â€¢Infections / Trauma requiring ACDF •ACDF Procedures combined with posterior surgeries •Patients with more than 2 level pathology •Severe medical co-morbidities precluding surgery •Patients who have undergone surgery in Cervical region previously.
结局指标
主要结局
Fusion
时间窗: Baseline,1,3,6,12 months
次要结局
- Visual Analogue Scale (VAS) score pain assessment, mJOA (modified Japanese Orthopaedic Association) score, NDI (Neck disability index) and Odom’s criteria(Baseline,1,3,6,12 months)