Comparison of Posterior Muscle-preserving Selective Laminectomy and Laminectomy With Fusion for Treating Degenerative Cervical Myelopathy: Myelopathy Randomized Controlled Trial (MyRanC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The primary endpoint will be reoperation for any reason to reflect whether laminectomy alone or laminectomy with instrumented fusion results in fewer reoperations without increasing the frequency of complications.
研究概览
简要总结
Background:
Degenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion.
Methods/Design:
This is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM.
Secondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years.
Discussion:
This will be the first randomized controlled trial comparing two of the most common surgical treatments for DCM; the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the MyRanC study will provide surgical treatment recommendations for DCM. This may result in improvements in surgical treatment and clinical practice regarding DCM.
详细描述
Background:
Degenerative cervical myelopathy (DCM) is characterized by neck pain and stiffness, weakness and paresthesia of the extremities, sphincter disturbance and bowel and balance disorder. DCM is the most common cause of spinal cord dysfunction in the elderly worldwide (1) and the incidence is 41 per million within North America (2). The mean age for symptoms is 64 years of age, more men than women, 2.7:1, are affected and the most common level is C5-C6 (3).
Mechanism:
DCM is typically the consequence of degenerative disc herniation, osteophyte formation and hypertrophy of the ligamentum flavum that compress the spinal cord. Ossification of the posterior longitudinal ligament (OPLL), which is more prevalent in the Asian population, may also cause compression of the spinal cord.
With non-operative treatments, i.e. medication and physiotherapy, 20-60% of the patients deteriorate neurologically and surgical treatment is indicated (4).
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
- •Age >18 years
- •1-4 levels of cervical degenerative myelopathy in the subaxial spine, C3-C7, without or with deformity not exceeding exclusion criteria, see below.
- •Eligible for both treatments
- •Ability to understand and read Swedish language
- •Symptomatic myelopathy with at least one clinical sign of myelopathy
- •No previous spine surgery
- •Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
- •Personally, signed and dated informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the trial
- •Definition of kyphosis - cSVA > 40 mm and/or C2-C7 Cobb > 10° kyphosis. Definition of spondylolisthesis - anterior slippage of > 2 mm on cervical radiographs taken in the neutral position.
排除标准
- •Local kyphosis; a modified K-line minimum interval distance (INT) of <4 mm
- •Spondylolisthesis >4 mm and simultaneous translation >2 mm on lateral flexion/extension radiographs
- •Soft disc herniations only (no signs of osteophyte formation and hypertrophy of the ligamentum flavum)
- •Active infection
- •Inflammatory disease (i.e., rheumatoid arthritis or ankylosing spondylitis or DISH)
- •Systemic disease including HIV
- •Lumbar or thoracic spinal disease to the extent that surgical consideration is probable or anticipated within 6 months after the cervical surgical treatment (significant lumbar stenosis as defined by Schizas C or worse).
- •Parkinson´s disease
- •Drug abuse, dementia, or other reason to suspect poor adherence to follow-up
- •Previous cervical spine surgery
结局指标
主要结局
The primary endpoint will be reoperation for any reason to reflect whether laminectomy alone or laminectomy with instrumented fusion results in fewer reoperations without increasing the frequency of complications.
时间窗: Recorded at 5 years of follow-up
Reoperation will be considered in case of: * Postoperative hematoma or reperfusion injury with neurologic deterioration within hours/days after the primary surgery. * Change in sagittal alignment (kyphosis, DJK of more than 40 mm cSVA and/or C2-C7 Cobb \< -10°) with corresponding symptoms of camptocormia/increased pain/neurological deterioration. * ASP defined as degenerative changes on an adjacent level diagnosed with MRI and concomitant symptoms of myelopathy and/or radiculopathy. * Implant failure (clear radiolucency around \>1 screw or rod breakage with increased neck pain and/or neurologic deterioration). * Postoperative infection that requires revision surgery.
次要结局
- Change from baseline in myelopathy score on the Nurick scale at 2 years.(Measured at baseline and 2 years of follow-up)
- Change from baseline in participants disability score on the Neck disability index (NDI) at 2 years.(Measured at baseline and 2 years of follow-up)
- Difference in number of participants with treatment-related adverse events in both groups at 5 years.(Recorded at 5 years of follow-up)
- Change from baseline in myelopathy score on the patient derived modified Japanese Orthopedic Association scale (P-mJOA) at 2 years.(Measured at baseline and 2 years of follow-up)
- Change from baseline in the patient Quality of life five dimensions (EQ-5D index) at 2 years.(Measured at baseline and 2 years of follow-up)
- Change from baseline in pain scores on the Numeric rating scale (NRS) at 2 years.(Measured at 2 years of follow-up)
- Change at baseline in number of participants with psychological impairment on the Hospital anxiety and depression scale (HADS) in both groups.(Measured at baseline)
- Change from baseline in myelopathy on the 10-s grip and release test at 2 years.(Measured at baseline and 2 years of follow-up)
- Change from baseline in myelopathy on the 10-s foot-tapping speed test at 2 years.(Measured at baseline and 2 years of follow-up)
- Change in indirect societal costs at one years of follow-up.(Recorded at 1 year of follow-up)
- Change from baseline in sagittal alignment on neutral radiographs at 5 years.(Assessed preoperatively and at 5 years of follow-up)
- Mortality(Recorded at 5 years of follow-up)
- Change in number of satisfied participants on the patient global assessment in both groups at 2 years.(Measured at baseline and 2 years of follow-up)
- Number of participants with change in adjacent segment pathology (ASP) on MRIs from baseline to 5 years of follow-up.(Assessed preoperatively and at 5 years of follow-up)
- Number of participants with change in compression of the spinal cord on the index level on MRIs from baseline to 5 years of follow-up.(Assessed preoperatively and at 5 years of follow-up)
- Change in direct costs between the groups at 1 year of follow-up.(Recorded at 1 year of follow-up.)
研究者
Anna Mac Dowall
Consultant
Uppsala University Hospital