Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Muscle Strength
研究概览
简要总结
Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.
详细描述
Background: Motor deficits owing to neural compression caused by lumbar disc herniation are a common problem encountered in spine surgery. Microdiscectomy is considered the preferred procedure for the treatment of limb paresis related to a herniated disc. Nevertheless, there is a restricted number of clinical studies in the literature investigating the role of preoperative factors that could influence the postoperative outcome in these patients.
Aim: To investigate the prognostic factors determining the outcome in patients with lower limb paresis caused by a herniated lumbar disc subjected to microdiscektomy.
Study type: Primary clinical research, observational prognostic study. Materials: Patients suffering from a motor deficit due to lumbar disc herniation to undergo lumbar microdiscectomy in three neurosurgical departments.
Protocol: Prospective multicenter study. This research will discover the prognostic value of two primary and five secondary preoperative factors. Primary factors: a) the severity of paresis, b) the duration of paresis. Secondary factors: a) age, b) body mass index, c) diabetes mellitus, d) anatomic location of the herniated disc, e) morphology of the herniated disc.
Outcomes: The key evaluation criterion is the muscle strength of the most severely affected lower limb muscle according to the six-point (0-5) Medical Research Counsil (MRC) Scale for Muscle Strength. After the comparison between the postoperative and preoperative muscle strength, the outcome of paresis will be recorded as: a) full recovery, b) partial recovery or c) no recovery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
- •Age (years) > 17
排除标准
- •Age (years) < 18
- •Medical history of lumbar spine surgery
- •Absence of limb paresis
- •Motor deficit caused by other than disk herniation aetiologies
- •Reoperation within 6 months after microdiskectomy
- •Microdiskectomy at more than one level
- •Cauda equina syndrome
- •Peripheral neuropathy
研究组 & 干预措施
Patients with limb paresis due to lumbar disk herniation undergoing microdiskectomy
Patients suffering from motor deficit because of lumbar disk herniation scheduled to undergo single-level microdiskectomy.
结局指标
主要结局
Muscle Strength
时间窗: Perioperative
The strength of lower main muscles will be assessed and will be rated according to the Medical Research Council Scale for Muscle Strength. The scale takes values between 0 and 5, with 5 being the best possible (healthy).
Duration of paresis before surgical treatment
时间窗: Baseline
Time between the initiation of paresis and surgical treatment measured in days
次要结局
- Age(Baseline)
- Obesity(Baseline)
- Diabetes Melitus(Baseline)
- Hernia location(Baseline)
- Hernia morphology(Baseline)
- Level of Pain(Perioperative)
- Functionality(Perioperative)
- Quality of life assessment(Perioperative)