The Effect of Lordosis on Clinical Outcome After Spinal Fusion for One-level Degenerative Spondylolysthesis

Spinal Fusion Clinical Trial

Official title:

The Effect of Lordosis on Long-term Clinical Outcome and Sagittal Balance Parameters After TLIF for One-level Degenerative Spondylolysthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174144
• Other study ID #: 0120-259/2019/6
• Status: Completed
• Start date: December 12, 2019
• Est. completion date: June 23, 2023

Study information

• Verified date: June 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Degenerative spondylolisthesis is a common spinal degenerative disease. It is defined as the slippage of one vertebrae on the vertebrae bellow. In the process of spinal ageing and spinal joint degeneration, the spine becomes subjected to degenerative development that results in joint instability, shifting of vertebrae and can be responsible for a progressive kyphosis of the lumbar spine and sagittal imbalance with forward inclination of the trunk and chronic low back pain development. To address these changes and restore stability, lumbar spinal fusion has been developed and is nowadays a common procedure for unstable degenerative spine disorders.

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.

Description:

TLIF (transforaminal interbody fusion) is a safe and effective treatment option for single-level lumbar degenerative disease. It is less invasive, yields good outcomes and has fewer complications after long-term follow up compared to other fusion techniques. In literature, many studies have compared sagittal parameters and functional outcomes in single-level TLIF surgery. In most literature reports, however, the fusion was performed at different lumbar levels, depending on the characteristics of the studied cohort. As demonstrated by Roussouly et. al. in the asymptomatic population, the L4 vertebra represents the apex of lumbar lordosis and is the most suitable site for lordosis correction. There are several reported surgical techniques and methods to obtain adequate lordosis correction during TLIF.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 23, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with one-level degenerative spondylolysthesis treated with single-level TLIF at Department of Orthopaedic surgery of Ljubljana University medical centre between 2011 and 2013.

• TLIF performed at L3/4 or L4/5

Exclusion Criteria:

• Patients who refuse to participate in study or do not respond to our invitation

• 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

Related Conditions & MeSH terms

• Lordosis
• Spinal Fusion
• Spondylolisthesis
• Spondylolisthesis Degenerative

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI questionnaire	The Oswestry Disability Index is an important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. For each section the total possible score is 5. If all 10 sections are completed the maximal score is 50.	7-9 years after TLIF procedure
Primary	LL	Radiographic evaluation of lumbar lordosis (LL): the angle between the upper endplate of the first lumbar vertebrae (L1) and the sacral endplate (S1).	7-9 years after TLIF procedure
Primary	SL	Radiographic evaluation of segmental lordosis (SL): the angle between the cranial endplate of the upper and caudal endplate of the lower vertebrae of the operated segment.	7-9 years after TLIF procedure
Secondary	PT	Radiographic evaluation of pelvic tilt (PT): the angle between the vertical line and the line going through the middle of the femoral heads and the middle point of the sacral endplate.	7-9 years after TLIF procedure
Secondary	SS	Radiographic evaluation of sacral slope (SS): the angle between sacral endplate and the horizontal line.	7-9 years after TLIF procedure
Secondary	SVA	Radiographic evaluation of sagittal vertical axis (SVA): a horizontal distance between the posterior end of the sacral endplate and the vertical line extended through the middle of seventh cervical vertebrae.	7-9 years after TLIF procedure