An observational study in Spondylolisthesis Degenerative and Spinal Fusion, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by University Medical Centre Ljubljana · Observational
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.
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.
30 studies on the registry are indexed under Lordosis; 5 are open to participants now.
This study's enrollment of 32 is below the median of 59 across 14 observational studies indexed under Lordosis.
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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.
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Exclusion Criteria:
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.
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.
Time frame: 7-9 years after TLIF procedure
LL
Radiographic evaluation of lumbar lordosis (LL): the angle between the upper endplate of the first lumbar vertebrae (L1) and the sacral endplate (S1).
Time frame: 7-9 years after TLIF procedure
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.
Time frame: 7-9 years after TLIF procedure
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.
Time frame: 7-9 years after TLIF procedure
SS
Radiographic evaluation of sacral slope (SS): the angle between sacral endplate and the horizontal line.
Time frame: 7-9 years after TLIF procedure
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.
Time frame: 7-9 years after TLIF procedure
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Starting within 1 year after publication.
Access criteria: IPD and any additional supporting information will be shared by request with the Principal investigator.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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