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Lumbar Spinal StenosisTUBE-FUSENCT07489508

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

An observational study of Lumbar Spinal Stenosis and Degenerative Lumbar Spondylolisthesis, run by University of Valencia at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 years and older
How many people
246 participants
Where
2 sitesSpain
Study dates
1 Jan 2000to 4 Mar 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Consorcio Hospital General Universitario de Valencia

    Valencia, Valencia, 46015

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46015

Other trials in Spain

About this study

Official 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

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.

Read the 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.

Keywords
Lumbar Spinal Stenosis, Tubular Decompression, Minimally Invasive Spine Surgery, Percutaneous Rhizotomy, Transfacetal TLIF, Lumbar Fusion, Degenerative Spondylolisthesis, Neurogenic Claudication, Microsurgical Decompression, Elderly Patients, Spine Degeneration
Medical subject headings
Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07489508
Study groupRoleWhat they receive
Tubular Decompression OnlyThis 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 + RhizotomyThis 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 FusionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    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 (%)

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

Secondary outcomes (9)

  1. Change in Oswestry Disability Index (ODI)

    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%)

    Measured: Preoperative baseline; 1 month; 6 months; 12 months

  2. Postoperative Complications

    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 (%)

    Measured: From surgery to 12 months postoperative follow-up

  3. Presence and Grade of Degenerative Spondylolisthesis

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

    Unit of Measure: Grade (0-IV)

    Measured: Preoperative imaging evaluation

  4. Need for Multisegmental Percutaneous Rhizotomy

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

    Percentage of participants (%)

    Measured: Within first postoperative year

  5. Rate of Subsequent Decompression or Reoperation

    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 (%)

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

  6. Improvement in Walking Tolerance

    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)

    Measured: Preoperative baseline; 1 month; 6 months; 12 months

  7. Improvement in Neurogenic Claudication Symptoms

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

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

    Measured: Preoperative baseline; 1 month; 6 months; 12 months

  8. Change in Japanese Orthopaedic Association Score (JOA)

    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)

    Measured: Preoperative baseline; 1 month; 6 months; 12 months

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

    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)

    Measured: Preoperative baseline; 1 month; 6 months; 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2026
  2. Study start1 Jan 2000
  3. Primary completion1 Mar 2026
  4. Study completion4 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
246 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07489508
Sponsor's protocol ID
CEIm 15-2026
Acronym
TUBE-FUSE
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Publications

  • Aygun H, Abdulshafi K. Unilateral Biportal Endoscopy Versus Tubular Microendoscopy in Management of Single Level Degenerative Lumbar Canal Stenosis: A Prospective Study. Clin Spine Surg. 2021 Jul 1;34(6):E323-E328. doi: 10.1097/BSD.0000000000001122.

    PubMed 33470660

  • Ohtomo N, Nakamoto H, Miyahara J, Yoshida Y, Nakarai H, Tozawa K, Fukushima M, Kato S, Doi T, Taniguchi Y, Matsubayashi Y, Higashikawa A, Takeshita Y, Kawamura N, Inanami H, Tanaka S, Oshima Y. Comparison between microendoscopic laminectomy and open posterior decompression surgery for single-level lumbar spinal stenosis: a multicenter retrospective cohort study. BMC Musculoskelet Disord. 2021 Dec 20;22(1):1053. doi: 10.1186/s12891-021-04963-6.

    PubMed 34930238

  • Zhang J, Liu TF, Shan H, Wan ZY, Wang Z, Viswanath O, Paladini A, Varrassi G, Wang HQ. Decompression Using Minimally Invasive Surgery for Lumbar Spinal Stenosis Associated with Degenerative Spondylolisthesis: A Review. Pain Ther. 2021 Dec;10(2):941-959. doi: 10.1007/s40122-021-00293-6. Epub 2021 Jul 28.

    PubMed 34322837

  • Oyama R, Arizono T, Inokuchi A, Imamura R, Hamada T, Bekki H. Comparison of Microendoscopic Laminotomy (MEL) Versus Spinous Process-Splitting Laminotomy (SPSL) for Multi Segmental Lumbar Spinal Stenosis. Cureus. 2022 Feb 9;14(2):e22067. doi: 10.7759/cureus.22067. eCollection 2022 Feb.

    PubMed 35295365

  • Algarni N, Al-Amoodi M, Marwan Y, Bokhari R, Addar A, Alshammari A, Alaseem A, Albishi W, Alshaygy I, Alabdullatif F. Unilateral laminotomy with bilateral spinal canal decompression: systematic review of outcomes and complications. BMC Musculoskelet Disord. 2023 Nov 21;24(1):904. doi: 10.1186/s12891-023-07033-1.

    PubMed 37990183

  • Shu L, Mu Q, Dai F, Zhao W, Syeda MZ, Wang Y. Contralateral approach using microscope and tubular retractor system for ipsilateral decompression of lumbar degenerative lateral recess stenosis associated with narrow spinal canal. Front Neurol. 2024 Apr 17;15:1387801. doi: 10.3389/fneur.2024.1387801. eCollection 2024.

    PubMed 38699053

  • Hermansen E, Austevoll IM, Hellum C, Storheim K, Myklebust TA, Aaen J, Banitalebi H, Anvar M, Rekeland F, Brox JI, Franssen E, Weber C, Solberg TK, Furunes H, Grundnes O, Brisby H, Indrekvam K. Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224291. doi: 10.1001/jamanetworkopen.2022.4291.

    PubMed 35344046

  • Drossopoulos PN, Ononogbu-Uche FC, Tabarestani TQ, Huang CC, Paturu M, Bardeesi A, Ray WZ, Shaffrey CI, Goodwin CR, Erickson M, Chi JH, Abd-El-Barr MM. Evolution of the Transforaminal Lumbar Interbody Fusion (TLIF): From Open to Percutaneous to Patient-Specific. J Clin Med. 2024 Apr 14;13(8):2271. doi: 10.3390/jcm13082271.

    PubMed 38673544

  • Prabhu MC, Jacob KC, Patel MR, Pawlowski H, Vanjani NN, Singh K. History and Evolution of the Minimally Invasive Transforaminal Lumbar Interbody Fusion. Neurospine. 2022 Sep;19(3):479-491. doi: 10.14245/ns.2244122.061. Epub 2022 Sep 30.

    PubMed 36203277

  • Suzuki A, Nakamura H. Microendoscopic Lumbar Posterior Decompression Surgery for Lumbar Spinal Stenosis: Literature Review. Medicina (Kaunas). 2022 Mar 4;58(3):384. doi: 10.3390/medicina58030384.

    PubMed 35334560

  • Spetzger U, Bertalanffy H, Naujokat C, von Keyserlingk DG, Gilsbach JM. Unilateral laminotomy for bilateral decompression of lumbar spinal stenosis. Part I: Anatomical and surgical considerations. Acta Neurochir (Wien). 1997;139(5):392-6. doi: 10.1007/BF01808872.

    PubMed 9204106

  • Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.

    PubMed 18287602

  • Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.

    PubMed 27074067

  • Austevoll IM, Hermansen E, Fagerland MW, Storheim K, Brox JI, Solberg T, Rekeland F, Franssen E, Weber C, Brisby H, Grundnes O, Algaard KRH, Boker T, Banitalebi H, Indrekvam K, Hellum C; NORDSTEN-DS Investigators. Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis. N Engl J Med. 2021 Aug 5;385(6):526-538. doi: 10.1056/NEJMoa2100990.

    PubMed 34347953

  • Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.

    PubMed 27074066

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis and Degenerative Lumbar Spondylolisthesis, run by University of Valencia at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for Lumbar Fusion (TLIF) After Minimally Invasive Decompression (time frame: From index surgery to last available follow-up (minimum 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07489508, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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