Comparison of Cervical Laminectomy to Cervical Laminoplasty* in Patients With Cervical Myelopathy or Myeloradiculopathy Due to Multiple Level Cervical Spinal Canal Stenosis * ARCH™ Fixation System by SYNTHES
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
研究概览
简要总结
The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the laminoplasty group is not inferior to the laminectomy group.
详细描述
Historically, cervical laminectomy has been proven to be effective in the treatment of symptomatic patients with cervical myelopathy. This standard procedure is employed to accomplish posterior decompression of the cervical spinal cord in patients with multi-level cervical spinal stenosis who have normal or near normal cervical spinal curvature and alignment without associated instability. Laminoplasty was developed in Japan as an alternative to the laminectomy procedure with the intent to reduce post-operative morbidity after dorsal cervical spinal cord decompression, neck pain and to maintain the relative stability of the cervical spine after multi-level decompression.
The goal of both the laminoplasty and laminectomy procedures is to provide spinal cord decompression by enlargement of the spinal canal. A potential benefit of laminoplasty compared to laminectomy is to preserve stability and range of motion of the cervical spine without complete disruption/removal of the posterior laminae, spinous processes and interspinous ligamentous structures. Various authors have described different laminoplasty techniques; all preserve the lamina and expand the size of the spinal canal by fixing the freed or partially freed lamina in a more posterior position.
The primary study hypothesis is that, patients treated with laminoplasty with ARCH fixation (Treatment Group) have clinical and radiographic outcomes as assessed by valid outcomes measures, is not inferior to patients treated with laminectomy (Control Group)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All must be met for inclusion in the study.
- •The patient must be at least 18 years of age and have no evidence of developmental anomaly of the cranial cervical junction and/or cervical spine
- •The patient has the diagnosis of cervical myelopathy
- •The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
- •The patient signs the study informed consent form.
排除标准
- •Primary symptoms and signs of cervical radiculopathy (only) without myelopathy.
- •Presence of primary focal anterior compression of the cervical spinal cord.
- •Ossification of the ligamentum flavum.
- •Previous surgery of the cervical spine.
- •Tumor, infection, or trauma of the cervical spine or cord.
- •Segmental instability - Pregnant or interested in becoming pregnant during the study follow-up period.
- •Known sensitivity to device materials.
- •Currently being treated or intends to be treated postoperatively with other devices for the same disorder (e.g., electrical stimulation devices, pain control devices, etc.).
- •Currently a participant in any other study related to the treatment of cervical spinal disorders.
- •Mentally incompetent, or unable to comply with the follow up regime
结局指标
主要结局
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
时间窗: 12 months
Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))\*100
Sagittal Angle Success
时间窗: 12 months
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Incidence of Surgical Interventions
时间窗: up to 24 months
Success defined as a lack of revision, removal or addition of supplemental fixation.
次要结局
- Pain Scores on the Visual Analog Scale(Up to 24 months)
- Functional Improvement Using the Neck Disability Index (NDI)(up to 24 months)
- Motor Deficit(up to 24 months)
- Range of Motion(up to 24 months)
- Extent of Spinal Canal/Cord Decompression(up to 24 months)
- Quality of Life Improvement Using the SF-12 Scale(up to 24 months)
- Sagittal Canal Diameter(up to 24 months)
- Reflex Evaluation(up to 24 months)
- Sensory Deficit(up to 24 months)