跳至主要内容
临床试验/NCT06886802
NCT06886802招募中不适用

Multicentric Case Series of Uniportal Endoscopic Posterior Cervical Decompression for Cervical Spinal Stenosis

TecSalud Investigación Clínica1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Change in Cervical Disability (Neck Disability Index)

研究概览

简要总结

Cervical spinal stenosis is a condition that can cause pain, sensory disturbances, and motor deficits due to the compression of neural structures in the cervical 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 anterior decompression and posterior open surgery, have proven effective but carry risks such as vascular or nerve injuries and postoperative pain.

This study evaluates a minimally invasive surgical approach called Posterior Uniportal Endoscopic Cervical Decompression as an alternative to traditional methods for patients with cervical spinal stenosis. The main objective is to assess changes in neurological deficits and disability related to cervical pain 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 50 patients from three medical centers in Mexico. Participants must have symptomatic cervical spinal stenosis that persists despite at least three months of conservative treatment. Eligible patients will undergo Posterior Uniportal Endoscopic Cervical Decompression, a technique that allows precise nerve decompression through a small incision, minimizing damage to surrounding tissues. Standardized clinical assessment tools, including the modified Japanese Orthopaedic Association (mJOA) scale, Neck Disability Index (NDI), 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 Posterior Uniportal Endoscopic Cervical Decompression effectively improves neurological function and reduces disability while maintaining a favorable safety profile. Findings from this study could support the adoption of minimally invasive endoscopic techniques as a viable option for treating cervical spinal stenosis, potentially leading to faster recovery times and reduced surgical complications compared to traditional methods.

详细描述

Cervical spinal stenosis is a condition characterized by the narrowing of the cervical spinal canal, leading to compression of the neural structures. This can cause chronic pain, sensory disturbances, and motor deficits, significantly impairing the quality of life. While conservative management, including physical therapy, analgesics, and steroid injections, can provide symptomatic relief for some patients, others with persistent neurological deficits may require surgical intervention. Traditional surgical techniques, such as anterior cervical decompression and fusion or posterior open decompression, have been effective but carry risks such as vascular injury, neurological complications, and postoperative pain.

This study investigates the use of Posterior Uniportal Endoscopic Cervical Decompression, 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 related to cervical pain 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 50 patients diagnosed with cervical 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 Posterior Uniportal Endoscopic Cervical Decompression, a technique 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 foraminotomies or 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 cervical spinal stenosis (Kang classification grade I-III), and the presence of neurological symptoms unresponsive to at least three months of conservative management. Exclusion criteria include prior cervical surgery at the affected level, active infections, systemic inflammatory diseases, vertebral instability, congenital spinal malformations, and contraindications for general anesthesia.

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.
  • •Patients with cervical canal stenosis grade I-III according to the Kang 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 posterior uniportal endoscopic cervical decompression for cervical canal stenosis.

排除标准

  • •Inability to read or write.
  • •Prior cervical surgeries at the levels to be treated.
  • •Infectious symptoms or concomitant rheumatologic diseases.
  • •Criteria of cervical vertebral instability.
  • •Congenital spinal malformations.
  • •Disc herniation at the same cervical level to be operated on.
  • •Medullary hyperintensity on T2-weighted magnetic resonance imaging in the level(s) to be treated.

研究组 & 干预措施

Cervical Spinal Stenosis Cases

Patients diagnosed with cervical spinal stenosis who exhibit persistent neurological deficits and pain despite receiving at least three months of conservative treatment. All participants have elected to undergo Posterior Uniportal Endoscopic Cervical Decompression. 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: Posterior Uniportal Endoscopic Cervical Decompression (Procedure)

结局指标

主要结局

Change in Cervical Disability (Neck Disability Index)

时间窗: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

This measure assesses disability related to cervical pain using the Neck Disability Index (NDI), a validated instrument scored from 0 (no disability) to 100 (maximum disability). It quantifies the impact of cervical pain on daily activities and overall function. Changes in NDI scores over time will reflect the effectiveness of the surgical intervention in reducing pain-related disability.

Change in Neurological Function (Modified Japanese Orthopaedic Association Score)

时间窗: Baseline; 1 month, 3 months, 6 months, and 12 months postoperatively.

This measure evaluates neurological function using the Modified Japanese Orthopaedic Association (mJOA) scale. The mJOA score, which ranges from 0 (severe neurological deficits) to 18 (normal neurological function), assesses motor function, sensory deficits, and gait. Improvements in the mJOA score following surgery will be used as an indicator of enhanced neurological status.

次要结局

  • Duration of Surgery(Recorded intraoperatively.)
  • Intraoperative Blood Loss(Assessed during the surgical procedure.)
  • Rate of Perioperative Complications(Assessed 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.)
  • Duration of Hospitalization(Measured during the index hospitalization.)

研究者

发起方
TecSalud Investigación Clínica
申办方类型
Other
责任方
Sponsor

研究点 (1)

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