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

NCT04174144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2023-06-27

No results posted yet for this study

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.

Conditions

  • Spondylolisthesis Degenerative
  • Spinal Fusion

Interventions

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2022-12-22
Completion
2023-06-23

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04174144 on ClinicalTrials.gov