Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT
NCT ID: NCT04708977
Last Updated: 2021-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-02-08
2021-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: Indirect Decompression
Lateral lumbar interbody fusion (LLIF), with indirect decompression
One-level lateral lumbar interbody fusion with Indirect Decompression
One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
Group 2: Direct Decompression
Lateral lumbar interbody fusion (LLIF), with direct decompression
One-level lateral lumbar interbody fusion with Direct Decompression
One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access instruments. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
Additionally, direct decompression through midline or parasagittal approach will be utilized. A unilateral laminotomy or complete bilateral laminectomy may be performed.
Interventions
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One-level lateral lumbar interbody fusion with Indirect Decompression
One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
One-level lateral lumbar interbody fusion with Direct Decompression
One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access instruments. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
Additionally, direct decompression through midline or parasagittal approach will be utilized. A unilateral laminotomy or complete bilateral laminectomy may be performed.
Eligibility Criteria
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Inclusion Criteria
* Mobile degenerative spondylolisthesis
* Severe vertical foraminal stenosis
* Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain
* One-level central canal stenosis
* WITH neurogenic claudication
* As measured in preoperative MRI
* Oswestry Low Back Pain Disability Questionnaire score \> 35% (18/50)
* Failed 3 months of conservative treatment
* Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms
Exclusion Criteria
* Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
* Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
* Prior surgery at index disc level (discectomy, decompression, or fusion)
* History of spinal or vertebral infection of the lumbar spine
* History of vertebral fracture of the lumbar spine
* Current pregnancy or interest in becoming pregnant over the next 1 year
* Active infection-systemic or local
* Non-English speakers
18 Years
75 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Sravisht Iyer, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
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Isaacs RE, Sembrano JN, Tohmeh AG; SOLAS Degenerative Study Group. Two-Year Comparative Outcomes of MIS Lateral and MIS Transforaminal Interbody Fusion in the Treatment of Degenerative Spondylolisthesis: Part II: Radiographic Findings. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S133-44. doi: 10.1097/BRS.0000000000001472.
Kono Y, Gen H, Sakuma Y, Koshika Y. Comparison of Clinical and Radiologic Results of Mini-Open Transforaminal Lumbar Interbody Fusion and Extreme Lateral Interbody Fusion Indirect Decompression for Degenerative Lumbar Spondylolisthesis. Asian Spine J. 2018 Apr;12(2):356-364. doi: 10.4184/asj.2018.12.2.356. Epub 2018 Apr 16.
Nakashima H, Kanemura T, Satake K, Ishikawa Y, Ouchida J, Segi N, Yamaguchi H, Imagama S. Indirect Decompression on MRI Chronologically Progresses After Immediate Postlateral Lumbar Interbody Fusion: The Results From a Minimum of 2 Years Follow-Up. Spine (Phila Pa 1976). 2019 Dec 15;44(24):E1411-E1418. doi: 10.1097/BRS.0000000000003180.
Pimenta L. Less-invasive lateral lumbar interbody fusion (XLIF) surgical technique: video lecture. Eur Spine J. 2015 Apr;24 Suppl 3:441-2. doi: 10.1007/s00586-015-3948-4. No abstract available.
Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.
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Baird EO, McAnany SJ, Overley S, Skovrlj B, Guzman JZ, Qureshi SA. Accuracy of Percutaneous Pedicle Screw Placement: Does Training Level Matter? Clin Spine Surg. 2017 Jul;30(6):E748-E753. doi: 10.1097/BSD.0000000000000274.
Sellin JN, Mayer RR, Hoffman M, Ropper AE. Simultaneous lateral interbody fusion and pedicle screws (SLIPS) with CT-guided navigation. Clin Neurol Neurosurg. 2018 Dec;175:91-97. doi: 10.1016/j.clineuro.2018.10.013. Epub 2018 Oct 23.
Houten JK, Nasser R, Baxi N. Clinical assessment of percutaneous lumbar pedicle screw placement using theO-arm multidimensional surgical imaging system. Neurosurgery. 2012 Apr;70(4):990-5. doi: 10.1227/NEU.0b013e318237a829.
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Huntsman KT, Riggleman JR, Ahrendtsen LA, Ledonio CG. Navigated robot-guided pedicle screws placed successfully in single-position lateral lumbar interbody fusion. J Robot Surg. 2020 Aug;14(4):643-647. doi: 10.1007/s11701-019-01034-w. Epub 2019 Oct 17.
Boukebir MA, Berlin CD, Navarro-Ramirez R, Heiland T, Scholler K, Rawanduzy C, Kirnaz S, Jada A, Hartl R. Ten-Step Minimally Invasive Spine Lumbar Decompression and Dural Repair Through Tubular Retractors. Oper Neurosurg. 2017 Apr 1;13(2):232-245. doi: 10.1227/NEU.0000000000001407.
Sembrano JN, Tohmeh A, Isaacs R; SOLAS Degenerative Study Group. Two-year Comparative Outcomes of MIS Lateral and MIS Transforaminal Interbody Fusion in the Treatment of Degenerative Spondylolisthesis: Part I: Clinical Findings. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S123-32. doi: 10.1097/BRS.0000000000001471.
Hung M, Saltzman CL, Kendall R, Bounsanga J, Voss MW, Lawrence B, Spiker R, Brodke D. What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions? Clin Orthop Relat Res. 2018 Oct;476(10):2027-2036. doi: 10.1097/CORR.0000000000000419.
Other Identifiers
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2019-2228
Identifier Type: -
Identifier Source: org_study_id
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