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

NCT07489508 | Completed

• 1 other identifier: CEIm 15-2026
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Lumbar Spinal Stenosis; Degenerative Lumbar Spondylolisthesis; Neurogenic Claudication

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

Outcome Measures

Primary Outcomes (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 (%)

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

Secondary Outcomes (9)

• 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)

Study Arms (3)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Hospital General Universitario de Valencia: collaborator

Study Sites (2)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

Location

Related Publications (15)

• 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.

  PMID: 33470660 BACKGROUND

• 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.

  PMID: 34930238 BACKGROUND

• 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.

  PMID: 34322837 BACKGROUND

• 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.

  PMID: 35295365 BACKGROUND

• 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.

  PMID: 37990183 BACKGROUND

• 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.

  PMID: 38699053 BACKGROUND

• 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.

  PMID: 35344046 BACKGROUND

• 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.

  PMID: 38673544 BACKGROUND

• 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.

  PMID: 36203277 BACKGROUND

• 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.

  PMID: 35334560 BACKGROUND

• 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.

  PMID: 9204106 BACKGROUND

• 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.

  PMID: 18287602 BACKGROUND

• 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.

  PMID: 27074067 BACKGROUND

• 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.

  PMID: 34347953 BACKGROUND

• 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.

  PMID: 27074066 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 24, 2026
• Study Start: January 1, 2000
• Primary Completion: March 1, 2026
• Study Completion: March 4, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)