Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in Lumbar Disability (Oswestry Disability Index)
研究概览
简要总结
Lumbar spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the lumbar spine. While conservative treatments such as physical therapy and pain management can help some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical approaches, including open laminectomy, have proven effective but carry risks such as extensive muscle damage, considerable blood loss, postoperative spinal instability, and prolonged recovery times.
This study evaluates a minimally invasive surgical approach called unilateral laminotomy with bilateral lumbar decompression (ULBLD) using endoscopic uniportal technique as an alternative to traditional methods for patients with lumbar spinal stenosis. The main objective is to assess changes in neurological deficits and disability in patients with lumbar spinal stenosis following this procedure. The study will also document hospitalization duration, surgical time, blood loss, and the incidence of postoperative complications.
This multicenter, prospective case series will recruit 78 patients from three medical centers in Mexico. Participants must have symptomatic lumbar spinal stenosis that persists despite at least three months of conservative treatment. Eligible patients will undergo ULBLD using endoscopic uniportal technique, a method that allows precise nerve decompression through a small incision, minimizing damage to surrounding tissues. Standardized clinical assessment tools, including the Japanese Orthopaedic Association (JOA) scale for lumbar disease, Oswestry Disability Index (ODI), and Visual Analog Scale (VAS) for pain, will be used to evaluate outcomes at multiple time points over 12 months.
By comparing patients' preoperative and postoperative evaluations, the study aims to determine whether ULBLD using endoscopic uniportal technique effectively improves neurological function and reduces disability while maintaining a favorable safety profile. Findings from this study could lead to a more precise understanding of the impact of ULBLD on disability, pain, and health-related quality of life for patients with lumbar spinal stenosis.
详细描述
Lumbar spinal stenosis is a common degenerative condition characterized by narrowing of the lumbar spinal canal, resulting in compression of nerve roots and, in some cases, the spinal cord. This narrowing can be caused by degenerative changes such as hypertrophy of the ligamentum flavum, formation of osteophytes, intervertebral disc protrusion, and thickening of the facet joints. Although its prevalence increases with age, it can affect people of different age groups. Clinically, patients present symptoms such as lumbar pain, neurogenic claudication, paresthesias, and weakness in the lower extremities, which significantly decrease their quality of life. These symptoms limit the ability to perform daily activities and reduce functional independence, affecting the general well-being of individuals.
This study investigates the use of ULBLD using endoscopic uniportal technique, a minimally invasive surgical approach that offers targeted decompression through a single small incision while minimizing tissue disruption. The primary objective of the study is to evaluate changes in neurological deficits and disability in patients with lumbar spinal stenosis following this procedure. Secondary objectives include assessing the duration of hospitalization, surgical time, blood loss, and the incidence of postoperative complications.
This multicenter, prospective case series will recruit 78 patients diagnosed with lumbar spinal stenosis at three medical institutions in Mexico. The study will be conducted over a period of 24 months, with an initial 12-month patient recruitment phase, followed by postoperative follow-up assessments at predetermined time intervals up to one year. Participants will undergo ULBLD using endoscopic uniportal technique, a method designed to preserve spinal mobility while reducing compression on the nerve roots. The procedure will be performed under general anesthesia with continuous neurophysiological monitoring, including somatosensory evoked potentials, motor evoked potentials, and continuous electromyography. Using a working-channel endoscope, surgeons will perform laminotomies to remove compressive elements such as osteophytes, hypertrophic ligaments, or herniated disc material. The technique is aimed at achieving decompression with minimal disruption to the surrounding soft tissues.
Patients must meet specific inclusion criteria, including an age range of 18 to 75 years, confirmed diagnosis of lumbar spinal stenosis (Lee classification grade I-III), and the presence of neurological symptoms unresponsive to at least three months of conservative management. Exclusion criteria include prior lumbar surgery at the affected level, active infections, systemic inflammatory diseases, vertebral instability, congenital spinal malformations, and contraindications for general anesthesia.
Patient outcomes will be systematically evaluated using validated clinical assessment tools, including:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent to participate in the study.
- •Age ≥18 years and <75 years.
- •Patients with lumbar spinal stenosis grade I-III according to the Lee scale.
- •Radicular or myelopathic symptoms.
- •Having undergone complete conservative management, including physical therapy and analgesia, for at least 3 months.
- •Patients who have opted for ULBLD using endoscopic uniportal technique for lumbar spinal stenosis.
排除标准
- •Inability to read or write.
- •Prior lumbar surgeries at the levels to be treated.
- •Infectious symptoms or concomitant rheumatologic diseases.
- •Criteria of lumbar vertebral instability.
- •Congenital spinal malformations.
- •Disc herniation at the same lumbar level to be operated on.
- •Medullary hyperintensity on T2-weighted magnetic resonance imaging in the levels to be treated.
研究组 & 干预措施
Lumbar Spinal Stenosis Cases
Patients diagnosed with lumbar spinal stenosis who exhibit persistent neurological deficits and pain despite receiving at least three months of conservative treatment. All participants have elected to undergo ULBLD using endoscopic uniportal technique. They are being prospectively followed to evaluate improvements in neurological function and reductions in pain-related disability, as well as to document perioperative outcomes including surgical time, blood loss, hospital stay, and complications.
干预措施: Unilateral Laminotomy with Bilateral Lumbar Decompression (ULBLD) (Procedure)
结局指标
主要结局
Change in Lumbar Disability (Oswestry Disability Index)
时间窗: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.
This measure assesses disability related to lumbar pain using the Oswestry Disability Index (ODI), a validated instrument scored from 0% (no disability) to 100% (maximum disability). It quantifies the impact of lumbar pain on daily activities and overall function. Changes in ODI scores over time will reflect the effectiveness of the surgical intervention in reducing pain-related disability.
Change in Neurological Function (Japanese Orthopaedic Association Score for Lumbar Disease)
时间窗: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.
This measure evaluates neurological function using the Japanese Orthopaedic Association (JOA) scale for lumbar disease. The JOA score, which ranges from -6 to 29 points (where higher scores indicate better neurological function), assesses lumbar pain, lower extremity pain and walking capacity, clinical signs, and restriction in activities of daily living. Improvements in the JOA score following surgery will be used as an indicator of enhanced neurological status.
次要结局
- Duration of Surgery(Recorded intraoperatively.)
- Patient Satisfaction with Surgical Outcomes (Modified MacNab Criteria)(1 month, 3 months, 6 months, and 12 months postoperatively.)
- Duration of Hospitalization(Measured during the index hospitalization.)
- Rate of Perioperative Complications(Assessed 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.)
- Health-Related Quality of Life (EQ-5D-5L)(Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.)
- Change in Back Pain Intensity (Visual Analog Scale - Back)(Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.)
- Change in Lower Extremity Pain Intensity (Visual Analog Scale - Lower Extremity)(Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.)
- Intraoperative Blood Loss(Assessed during the surgical procedure.)