Retrospective Comparison of Tubular Decompression ± Rhizotomy Versus TLIF in Lumbar Spinal Stenosis (TUBE-FUSE)

March 17, 2026 updated by: Vicente Vanaclocha, University of Valencia

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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valencia
      • Valencia, Valencia, Spain, 46015
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Valencia, Spain, 46015
        • Hospital General Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients aged 50 years or older treated surgically for lumbar spinal stenosis at the General University Hospital of Valencia between 2000 and 2025. The population includes patients treated with tubular decompression alone, tubular decompression followed by rhizotomy, or primary TLIF decompression and fusion, according to routine clinical practice.

Description

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:

    1. Minimally invasive unilateral tubular decompression, or
    2. Minimally invasive unilateral tubular decompression followed by multisegmental percutaneous rhizotomy, or
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Tubular Decompression Only
This cohort includes patients with lumbar spinal stenosis who underwent minimally invasive unilateral tubular decompression with microscopic assistance as their primary surgical treatment. These patients showed satisfactory postoperative improvement and did not require additional procedures such as multisegmental percutaneous facet rhizotomy or subsequent TLIF fusion. All interventions were performed as part of routine clinical care, not as part of a research protocol.
Tubular Decompression + Rhizotomy
This cohort includes patients with lumbar spinal stenosis who initially underwent minimally invasive unilateral tubular decompression with microscopic assistance but experienced persistent or recurrent postoperative lumbar pain. As part of standard clinical care, these patients subsequently received multisegmental percutaneous facet rhizotomy. A research protocol directed no assignments or interventions; all treatments followed clinical indications during routine practice.
Primary TLIF Decompression and Fusion
This cohort includes patients with lumbar spinal stenosis who underwent primary transfacetal TLIF decompression and fusion as their initial surgical treatment. These patients did not present radiographic spinal instability; fusion was performed solely based on the treating surgeon's preference to decompress and fuse in one procedure. All surgeries were part of routine clinical care and were not assigned by a research protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)

Preoperative baseline; 1 month; 6 months; 12 months
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 (%)

From surgery to 12 months postoperative follow-up
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)

Preoperative imaging evaluation
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 (%)

Within first postoperative year
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 (%)

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

Preoperative baseline; 1 month; 6 months; 12 months
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)

Preoperative baseline; 1 month; 6 months; 12 months
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)

Preoperative baseline; 1 month; 6 months; 12 months
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)

Preoperative baseline; 1 month; 6 months; 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 4, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. This retrospective study uses clinical data obtained from standard medical records without prior consent for public data sharing. All analyses are performed on anonymized datasets stored securely within the institution, and IPD cannot be made publicly available due to privacy and data protection regulations (RGPD and national legislation).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Spinal Stenosis

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