The Effect of Lordosis on Clinical Outcome After Spinal Fusion for One-level Degenerative Spondylolysthesis
NCT ID: NCT04174144
Last Updated: 2023-06-27
Study Results
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Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2019-12-12
2023-06-23
Brief Summary
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In the past several years, studies that highlight the importance of sagittal balance analysis with the restoration of adequate lumbar lordosis, have emerged. However, it remains a challenge to determine the correct amount of lumbar lordosis that is required for each patient to maintain optimal post-fusion sagittal balance. Additionally, the relationship between pelvic incidence (PI) and impact of LL correction has been highlighted in literature. The position of fused vertebrae is of paramount importance, as sagittal alignment should be done with minimizing muscle work during posture. Failure to reach proper sagittal balance can result in compensatory mechanisms such as increased pelvic tilt (PT), cervical and thoracic segment hyperextension, and knee flexion. These compensatory mechanisms have adverse effects such as chronic pain, disability and muscle fatigue.
With this study the investigators aim to analyze long-term clinical and spinopelvic radiographic parameter outcomes of patients who underwent a one-level spinal fusion procedure for single level degenerative spondylolisthesis disease at a single institution.
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Detailed Description
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At Department of Orthopaedic surgery of Ljubljana University medical centre, TLIF is performed using a consistent brand of instrumentation. In knee-chest position, polyaxial pedicle screws (Xia®, Stryker Spine, Allendale, NJ, USA), combined with a crescent-shaped interbody cage (T-Plus®, Pioneer Surgical Technology, Marquette, MI, USA), bilateral facet joint removal and laminectomy on both sides are used. Compression over the rods is performed to obtain adequate segmental lordosis. The angle of lordosis correction is calculated according Schwab's formula (ideal lumbar lordosis (LL) = pelvic incidence (PI) + 9).
There is little published information regarding cohorts with long-term evaluation. As many authors suggested, changes in lordotic parameters can become clinically evident several years after the procedure. With this study's cohort analysis, a rarely reported link between spinopelvic parameters and long-term clinical evaluation will be demonstrated. Selected participants will be analyzed using the same protocol as preoperatively. A clinical examination will be made, ODI questionnaires will be administered and radiographic parameters on full-standing lateral radiographs, will be analyzed. Changes between preoperative and long-term postoperative parameters will be calculated and compared. For statistical analysis paired t-test and Pearson correlation will be used. All statistical tests will be two tailed and significance will be set at p\<0.05.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TLIF group
Participants with degenerative spondylolysthesis who underwent a single-level TLIF procedure.
Single-level TLIF
Transforaminal interbody fusion approach, using polyaxial pedicle screws (Xia®, Stryker Spine, Allendale, NJ, USA), combined with a crescent-shaped interbody cage (T-Plus®, Pioneer Surgical Technology, Marquette, MI, USA), bilateral facet joint removal and laminectomy.
Interventions
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Single-level TLIF
Transforaminal interbody fusion approach, using polyaxial pedicle screws (Xia®, Stryker Spine, Allendale, NJ, USA), combined with a crescent-shaped interbody cage (T-Plus®, Pioneer Surgical Technology, Marquette, MI, USA), bilateral facet joint removal and laminectomy.
Eligibility Criteria
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Inclusion Criteria
* TLIF performed at L3/4 or L4/5
Exclusion Criteria
* Patients with additional instrumental spinal surgery or spinal trauma
* Patients with additional types of adult spinal deformity
* Patients with inflammatory spinal conditions
* Patients with flexion contractures of the hips or knees
18 Years
ALL
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Klemen Bošnjak
Resident of Orthopaedic surgery
Principal Investigators
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Rok Vengust, M.D, PhD
Role: STUDY_CHAIR
Department of Orthopaedic surgery, University Medical Centre Ljubljana
Locations
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University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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References
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Barrey C, Roussouly P, Le Huec JC, D'Acunzi G, Perrin G. Compensatory mechanisms contributing to keep the sagittal balance of the spine. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S834-41. doi: 10.1007/s00586-013-3030-z. Epub 2013 Sep 20.
Barrey C, Darnis A. Current strategies for the restoration of adequate lordosis during lumbar fusion. World J Orthop. 2015 Jan 18;6(1):117-26. doi: 10.5312/wjo.v6.i1.117. eCollection 2015 Jan 18.
Cheng X, Zhang F, Zhang K, Sun X, Zhao C, Li H, Li YM, Zhao J. Effect of Single-Level Transforaminal Lumbar Interbody Fusion on Segmental and Overall Lumbar Lordosis in Patients with Lumbar Degenerative Disease. World Neurosurg. 2018 Jan;109:e244-e251. doi: 10.1016/j.wneu.2017.09.154. Epub 2017 Oct 5.
Ferrero E, Ould-Slimane M, Gille O, Guigui P; French Spine Society (SFCR). Sagittal spinopelvic alignment in 654 degenerative spondylolisthesis. Eur Spine J. 2015 Jun;24(6):1219-27. doi: 10.1007/s00586-015-3778-4. Epub 2015 Feb 5.
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.
Kuhta M, Bosnjak K, Vengust R. Failure to maintain segmental lordosis during TLIF for one-level degenerative spondylolisthesis negatively affects clinical outcome 5 years postoperatively: a prospective cohort of 57 patients. Eur Spine J. 2019 Apr;28(4):745-750. doi: 10.1007/s00586-019-05890-w. Epub 2019 Jan 24.
Le Huec JC, Aunoble S, Philippe L, Nicolas P. Pelvic parameters: origin and significance. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):564-71. doi: 10.1007/s00586-011-1940-1. Epub 2011 Aug 10.
Le Huec JC, Faundez A, Dominguez D, Hoffmeyer P, Aunoble S. Evidence showing the relationship between sagittal balance and clinical outcomes in surgical treatment of degenerative spinal diseases: a literature review. Int Orthop. 2015 Jan;39(1):87-95. doi: 10.1007/s00264-014-2516-6. Epub 2014 Sep 6.
Le Huec JC, Hasegawa K. Normative values for the spine shape parameters using 3D standing analysis from a database of 268 asymptomatic Caucasian and Japanese subjects. Eur Spine J. 2016 Nov;25(11):3630-3637. doi: 10.1007/s00586-016-4485-5. Epub 2016 Mar 7.
Liang Y, Shi W, Jiang C, Chen Z, Liu F, Feng Z, Jiang X. Clinical outcomes and sagittal alignment of single-level unilateral instrumented transforaminal lumbar interbody fusion with a 4 to 5-year follow-up. Eur Spine J. 2015 Nov;24(11):2560-6. doi: 10.1007/s00586-015-3933-y. Epub 2015 Apr 14.
Morvan G, Mathieu P, Vuillemin V, Guerini H, Bossard P, Zeitoun F, Wybier M. Standardized way for imaging of the sagittal spinal balance. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):602-8. doi: 10.1007/s00586-011-1927-y. Epub 2011 Aug 10.
Ould-Slimane M, Lenoir T, Dauzac C, Rillardon L, Hoffmann E, Guigui P, Ilharreborde B. Influence of transforaminal lumbar interbody fusion procedures on spinal and pelvic parameters of sagittal balance. Eur Spine J. 2012 Jun;21(6):1200-6. doi: 10.1007/s00586-011-2124-8. Epub 2011 Dec 17.
Roussouly P, Pinheiro-Franco JL. Biomechanical analysis of the spino-pelvic organization and adaptation in pathology. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):609-18. doi: 10.1007/s00586-011-1928-x. Epub 2011 Aug 2.
Schwab F, Lafage V, Patel A, Farcy JP. Sagittal plane considerations and the pelvis in the adult patient. Spine (Phila Pa 1976). 2009 Aug 1;34(17):1828-33. doi: 10.1097/BRS.0b013e3181a13c08.
Tye EY, Alentado VJ, Mroz TE, Orr RD, Steinmetz MP. Comparison of Clinical and Radiographic Outcomes in Patients Receiving Single-Level Transforaminal Lumbar Interbody Fusion With Removal of Unilateral or Bilateral Facet Joints. Spine (Phila Pa 1976). 2016 Sep;41(17):E1039-E1045. doi: 10.1097/BRS.0000000000001535.
Other Identifiers
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0120-259/2019/6
Identifier Type: -
Identifier Source: org_study_id
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