Patient Reported Recovery of Muscle Strength After Surgery for Cervical Radiculopathy, Impact of Duration and Severity on Recovery. A Population Based Study by NOrspine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- patient reported improvement of paresis (complete)
研究概览
简要总结
DCR surgery is generally recommended for patients with severe or progressive limb paresis. The incidence of motor weakness reported to be up to 70%, with a varying recovery rate up to 90%, and the prospects of recovery is most likely dependent on paresis severity and duration. Operative treatment could facilitate earlier recovery, but the evidence is weak and based on smaller and heterogeneous DCM/DCR populations. There is also a lack of knowledge concerning timing of surgery, i.e. the influence of paresis duration, surgical delay and preoperative paresis. It is also unclear if there is an association between the underlying DCR pathology (disc herniation, spondylosis or both) and prognosis. The aim of this sub-study is to assess the frequency and severity of limb preoperative paresis in patients operated for DCR, and to improve prognostication of recovery and timing of surgery. To the best of our knowledge, these issues have not been properly investigated previously.
New knowledge in this field is highly sought by clinicians and can Inform patients, and physicians in shared decision making, i.e. helping them to choose more wisely between different treatment strategies. New insight in this field would be also be useful in clinical guideline development, for reducing surgical practice variation, for modifying outcome expectations, improve patient selection (clinical guideline development) and clinical outcomes of DCR surgery.
详细描述
The most common cause of cervical operation is Degenerative cervical radiculopathy (DCR), i.e. a neural impingement by disc herniation or spondylotic changes. While pain is often the most prevalent indication of surgery, motor weakness is frequently reported and is associated with less favourable outcome.
Preoperative motor weakness is reported up to 70%. Some studies suggest that both the severity and duration of preoperative motor weakness are associated with persistent postoperative weakness, implying that delayed intervention may reduce the likelihood of full neurological recovery.
Moreover, current evidence does not establish whether surgery is preferable to conservative treatment in patients with motor weakness. The optimal timing of surgery and the grades of weakness most likely to benefit also remain unclear. A systematic review was unable to draw firm conclusions because studies varied substantially in strength assessment methods, outcome definitions, and follow-up duration.
Thomé et al. reported that, in lumbar radiculopathy, the association between early surgery and motor recovery was dependent on both baseline muscle grade and symptom duration.12 However, these findings may not be generalisable to cervical radiculopathy given key anatomical and pathological differences.
This study aims to evaluate the association between the preoperative duration and baseline severity (muscle strength grade) of motor weakness and complete strength recovery at 12 months after surgery for DCR. As a secondary, exploratory aim, we will assess whether there is a severity grade and/or duration window in which the probability of complete recovery is highest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery due to degenerative cervical radiculopathy with a preoperative muscle weakness
- •Posterior and anterior approach (ACDF/artificial disc replacement, posterior foramenotomi)
排除标准
- •Myelopathy as surgical indication
- •Tumor as surgical indication
- •Infection as surgical indication
- •Fracture as surgcial indication
- •Posterior fusion and laminectomy
- •Prior cervical surgery
- •Anterior corpectomy
结局指标
主要结局
patient reported improvement of paresis (complete)
时间窗: 12 month
Follow-up strength question (3 and 12 months): "If you had reduced strength (weakness) in your shoulder/arm/hand before the operation-has this changed?" Response options: * Has become completely normal * Has improved * Unchanged * Has worsened Primary endpoint derivation (12 months): * Complete recovery = Yes: "Has become completely normal". * Complete recovery = No: all other responses.
次要结局
- Neck disability index (NDI)(12 month)
- EuroQol-5D (EQ5D)(12 month)
- Patient and surgeon reported complications(12 month)
- NRS head(12 month)
- NRS neck(12 month)
- Improved or complete recovery(12 and 3 month)
研究者
Tore Solberg
Consultant neurosurgeon
University Hospital of North Norway