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

June 25, 2023 updated by: Klemen Bošnjak, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from patients who underwent a single-level TLIF procedure at Department of Orthopaedic surgery of Ljubljana University medical centre between 2011 and 2013.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TLIF group
Participants with degenerative spondylolysthesis who underwent a single-level TLIF procedure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ODI questionnaire
Time Frame: 7-9 years after TLIF procedure
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
LL
Time Frame: 7-9 years after TLIF procedure
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
SL
Time Frame: 7-9 years after TLIF procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PT
Time Frame: 7-9 years after TLIF procedure
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
SS
Time Frame: 7-9 years after TLIF procedure
Radiographic evaluation of sacral slope (SS): the angle between sacral endplate and the horizontal line.
7-9 years after TLIF procedure
SVA
Time Frame: 7-9 years after TLIF procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Rok Vengust, M.D, PhD, Department of Orthopaedic surgery, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

June 23, 2023

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-259/2019/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication and are in accordance with ethical standards of the National ethics committee of Slovenia on human experimentation and with the Helsinki Declaration of 1975.

IPD Sharing Time Frame

Starting within 1 year after publication.

IPD Sharing Access Criteria

IPD and any additional supporting information will be shared by request with the Principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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