- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489508
Retrospective Comparison of Tubular Decompression ± Rhizotomy Versus TLIF in Lumbar Spinal Stenosis (TUBE-FUSE)
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
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Valencia
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Valencia, Valencia, Spain, 46015
- Consorcio Hospital General Universitario de Valencia
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Valencia, Valencia, Spain, 46015
- Hospital General Universitario de Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Need for Lumbar Fusion (TLIF) After Minimally Invasive Decompression
Time Frame: From index surgery to last available follow-up (minimum 6 months)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Oswestry Disability Index (ODI)
Time Frame: Preoperative baseline; 1 month; 6 months; 12 months
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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
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Postoperative Complications
Time Frame: From surgery to 12 months postoperative follow-up
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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
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Presence and Grade of Degenerative Spondylolisthesis
Time Frame: Preoperative imaging evaluation
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Detection and grading of degenerative spondylolisthesis using the Meyerding grading system. Unit of Measure: Grade (0-IV) |
Preoperative imaging evaluation
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Need for Multisegmental Percutaneous Rhizotomy
Time Frame: Within first postoperative year
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Proportion of patients requiring multisegmental percutaneous facet rhizotomy due to persistent lumbar pain after initial decompression. Percentage of participants (%) |
Within first postoperative year
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Rate of Subsequent Decompression or Reoperation
Time Frame: From index surgery to last available follow-up (minimum 6 months)
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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)
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Improvement in Walking Tolerance
Time Frame: Preoperative baseline; 1 month; 6 months; 12 months
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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
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Improvement in Neurogenic Claudication Symptoms
Time Frame: Preoperative baseline; 1 month; 6 months; 12 months
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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
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Change in Japanese Orthopaedic Association Score (JOA)
Time Frame: Preoperative baseline; 1 month; 6 months; 12 months
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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
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Change in Visual Analog Scale (VAS) for Pain
Time Frame: Preoperative baseline; 1 month; 6 months; 12 months
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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
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm 15-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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