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Completed

NCT Number: NCT07489508

Retrospective Comparison of Tubular Decompression ± Rhizotomy Versus TLIF in Lumbar Spinal Stenosis

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorcio Hospital General Universitario de Valencia, Valencia, Spain

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About this study

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.

Findings from this study may help refine patient-selection criteria for minimally invasive decompression techniques and reduce the need for fusion procedures, particularly in elderly populations where surgical risk must be minimized. The results may also guide the design of future prospective studies to validate the long-term effectiveness of these treatment pathways.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Need for Lumbar Fusion (TLIF) After Minimally Invasive Decompression

    Time frame: 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 (%)

Secondary outcomes

  1. Change in Oswestry Disability Index (ODI)

    Time frame: Preoperative baseline; 1 month; 6 months; 12 months

    Change in disability level measured by the ODI questionnaire. Improvement is defined as postoperative minus baseline ODI score.

    Unit of Measure: Percentage points (0-100%)

  2. Postoperative Complications

    Time frame: From surgery to 12 months postoperative follow-up

    Incidence of postoperative complications, recorded as presence or absence of any complication (e.g., wound complications, dural tears, neurologic deficits, infection, unplanned reoperations). Each patient contributes a single binary outcome (complication: yes/no).

    Unit of Measure: Percentage of participants (%)

  3. Presence and Grade of Degenerative Spondylolisthesis

    Time frame: Preoperative imaging evaluation

    Detection and grading of degenerative spondylolisthesis using the Meyerding grading system.

    Unit of Measure: Grade (0-IV)

  4. Need for Multisegmental Percutaneous Rhizotomy

    Time frame: Within first postoperative year

    Proportion of patients requiring multisegmental percutaneous facet rhizotomy due to persistent lumbar pain after initial decompression.

    Percentage of participants (%)

  5. Rate of Subsequent Decompression or Reoperation

    Time frame: From index surgery to last available follow-up (minimum 6 months)

    Proportion of patients who required repeated lumbar decompression or any additional non-fusion spine surgery following the index minimally invasive decompression.

    Unit of Measure: Percentage of participants (%)

  6. Improvement in Walking Tolerance

    Time frame: Preoperative baseline; 1 month; 6 months; 12 months

    Change in walking tolerance measured as documented walking distance without neurogenic claudication symptoms. Improvement is postoperative minus baseline distance.

    Unit of Measure: Meters walked (m)

  7. Improvement in Neurogenic Claudication Symptoms

    Time frame: Preoperative baseline; 1 month; 6 months; 12 months

    Change in neurogenic claudication severity based on clinical documentation comparing postoperative with baseline status.

    Unit of Measure: Ordinal clinical scale (improved / unchanged / worsened)

  8. Change in Japanese Orthopaedic Association Score (JOA)

    Time frame: Preoperative baseline; 1 month; 6 months; 12 months

    Change in functional status measured by the Japanese Orthopaedic Association (JOA) score. Improvement is defined as postoperative minus baseline value.

    Unit of Measure: Points (0-29)

  9. Change in Visual Analog Scale (VAS) for Pain

    Time frame: Preoperative baseline; 1 month; 6 months; 12 months

    Change in pain intensity measured using the Visual Analog Scale (VAS). Improvement is defined as postoperative minus baseline VAS score.

    Unit of Measure: (0-10)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital General Universitario de Valencia

Registry information

Official study title

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

Acronym: TUBE-FUSE

Important dates

Study start
2000
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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