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临床试验/NCT07489508
NCT07489508已完成不适用

Retrospective Comparison of Tubular Decompression With or Without Multisegmental Rhizotomy Versus Transfacetal TLIF for the Treatment of Lumbar Spinal Stenosis: A 25-Year Observational Cohort Analysis

University of Valencia2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
246
试验地点
2
主要终点
Need for Lumbar Fusion (TLIF) After Minimally Invasive Decompression

研究概览

简要总结

This retrospective observational study examines clinical outcomes in patients with lumbar spinal stenosis who underwent minimally invasive tubular decompression, with or without subsequent multisegmental percutaneous rhizotomy, at the General University Hospital of Valencia over 25 years (2000-2025). The purpose of the study is to determine whether decompression alone provides sufficient long-term symptom improvement or whether additional spinal fusion (transfacetal TLIF) is needed in specific patient subgroups. By analyzing real-world data from routine clinical practice, this study aims to identify clinical, radiological, and demographic factors associated with the need for fusion surgery, particularly in older adults who may benefit from less invasive treatment strategies. No new interventions are performed as part of this study, and all data are obtained from existing medical records.

详细描述

Lumbar spinal stenosis is a common and disabling condition, particularly in older adults, often leading to neurogenic claudication and reduced quality of life. Traditional open decompression and fusion procedures may provide symptom relief but are associated with greater surgical morbidity, longer recovery times, and increased risk of complications, especially in elderly patients with multiple comorbidities. Minimally invasive surgical techniques, including tubular unilateral decompression and targeted multisegmental percutaneous rhizotomy, have been progressively adopted to reduce surgical trauma while preserving spinal stability.

Over the past 25 years, the Neurosurgery Department of the General University Hospital of Valencia has routinely applied a protocol in which patients with lumbar spinal stenosis undergo minimally invasive tubular decompression with microscopic assistance. Patients who continue to experience significant postoperative lumbar pain are considered for multisegmental facet rhizotomy as a second-step treatment. Transfacetal TLIF fusion has been reserved for cases presenting persistent instability, clinical deterioration, or inadequate response to the decompression-based strategy. This long-term clinical experience provides a unique opportunity to evaluate whether spinal fusion is truly required in all patients, or whether decompression alone-with or without adjunctive rhizotomy-offers sufficient clinical benefit.

This study is a retrospective observational cohort analysis of patients treated for lumbar spinal stenosis between 2000 and 2025 at the General University Hospital of Valencia. All procedures were part of routine clinical care and were not assigned by a research protocol. The study aims to compare outcomes among three groups: patients who improved with tubular decompression alone, those who required additional multisegmental rhizotomy due to persistent lumbar pain, and those who ultimately required TLIF fusion. Clinical, radiological, and demographic factors associated with each clinical pathway will be analyzed to determine predictors of success or failure of minimally invasive decompression strategies.

The primary objective is to identify the proportion of patients who required fusion surgery after initial minimally invasive decompression and to determine factors associated with the need for additional stabilization. Secondary objectives include evaluating postoperative functional improvement, assessing rates and types of postoperative complications, and examining the influence of degenerative spondylolisthesis or other anatomical variables on treatment outcomes.

All data are obtained exclusively from existing medical records, surgical notes, imaging studies, and standardized functional assessments (e.g., ODI, JOA, VAS). No new interventions, procedures, or contact with patients are required. Data are coded and anonymized before analysis to ensure compliance with ethical and data-protection standards.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 50 years or older.
  • Diagnosis of lumbar spinal stenosis confirmed by clinical assessment and imaging.
  • Underwent one of the following standard-of-care surgical pathways between 2000 and 2025:
  • Minimally invasive unilateral tubular decompression, or
  • Minimally invasive unilateral tubular decompression followed by multisegmental percutaneous rhizotomy, or
  • Primary transfacetal TLIF decompression and fusion.
  • Complete medical records available with at least 6 months of postoperative follow-up.
  • Surgery and follow-up performed at the General University Hospital of Valencia.

排除标准

  • Initial treatment consisting of lumbar fusion or pedicle screw instrumentation (except for patients in the primary TLIF decompression-and-fusion cohort).
  • Lumbar spinal stenosis secondary to trauma, tumor, infection, or prior surgery at the same level.
  • Degenerative spondylolisthesis grade III or higher.
  • Missing or incomplete clinical records preventing adequate outcome assessment.
  • Contraindications to surgery that altered the standard surgical pathway.

结局指标

主要结局

Need for Lumbar Fusion (TLIF) After Minimally Invasive Decompression

时间窗: From index surgery to last available follow-up (minimum 6 months)

Proportion of patients who required transfacetal TLIF fusion after initial minimally invasive unilateral tubular decompression, with or without subsequent multisegmental rhizotomy. Determined from operative reports and clinical records. Unit of Measure: Percentage of participants (%)

次要结局

  • Change in Oswestry Disability Index (ODI)(Preoperative baseline; 1 month; 6 months; 12 months)
  • Postoperative Complications(From surgery to 12 months postoperative follow-up)
  • Presence and Grade of Degenerative Spondylolisthesis(Preoperative imaging evaluation)
  • Need for Multisegmental Percutaneous Rhizotomy(Within first postoperative year)
  • Rate of Subsequent Decompression or Reoperation(From index surgery to last available follow-up (minimum 6 months))
  • Improvement in Walking Tolerance(Preoperative baseline; 1 month; 6 months; 12 months)
  • Improvement in Neurogenic Claudication Symptoms(Preoperative baseline; 1 month; 6 months; 12 months)
  • Change in Japanese Orthopaedic Association Score (JOA)(Preoperative baseline; 1 month; 6 months; 12 months)
  • Change in Visual Analog Scale (VAS) for Pain(Preoperative baseline; 1 month; 6 months; 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicente Vanaclocha

Associate Professor of Medicine

University of Valencia

研究点 (2)

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