Lumbar Discopathy Decompression with Lateral Interbody Fusion: Radiological and Clinical Outcomes

Single-Level Lateral Lumbar Interbody Fusion in Author's Modification: Clinical and Radiographic Outcomes

The aim of the study was to introduce a single-segment lumbar spine decompression and fusion with intervertebral implants through modified by the authors lateral lumbar approach. Functional, surgical and radiographic outcomes was evaluated.

Study Overview

• Status: Completed
• Conditions: Spine Degeneration; Fusion of Spine (Disease)

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Poland
  • Podkarpackie
    • Brzozów, Podkarpackie, Poland, 38-500
      • Subcarpatian Oncology Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We retrospectively reviewed the medical data of patients who underwent single-level LIF from January to December 2021 at the Orthopaedic Oncology Department in Brzozów and the Trauma and Orthopaedic Department in Stalowa Wola.

Description

Inclusion Criteria:

Single-segment L1-L4 spine discopathy.

Exclusion Criteria:

Any other spinal diseases. More than one level of discopathy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single level decompression and LLIF; Patients with single-segment L1-L4 spine discopathy treated with lumbar spine fusion modified by the authors were included in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the quality of life	the quality of life according to the EQ-VAS - Euro-Quality of Life Visual Analoque Score	3 months after the surgery
the functional status - Karnofsky scale	patients' neurological status, functional status according to the Karnofsky scale	3 months after the surgery
the functional status Oswestry Disability Index	patients' neurological status, functional status according to the ODI - Oswestry Disability Index	3 months after the surgery
the intensity of pain	the intensity of pain according to the VAS - Visual AnalogueScale score	3 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal	Based on pre- and postoperative MRI/RTG the following aspects were assessed: The Cross-Sectional Area of the Spinal Canal, the width and depth of disc extrusion, and the width of the lateral recesses of the spinal canal, anterior disc height lumbar lordosis angle and lumbar segmental angle.	3 months after the surgery
Radiographic Outcomes: The Height and Width of the Intervertebral Foramina	Based on pre- and postoperative MRI/RTG the following aspects were assessed: The Height and Width of the Intervertebral Foramina	3 months after the surgery
Radiographic Outcomes: lumbar segmental angle.	Based on pre- and postoperative MRI/RTG the following aspects were assessed: lumbar segmental angle.	3 months after the surgery

Collaborators and Investigators

• Sponsor: Podkarpackie Oncological Center

Publications and helpful links

General Publications

• Schizas C, Theumann N, Burn A, Tansey R, Wardlaw D, Smith FW, Kulik G. Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images. Spine (Phila Pa 1976). 2010 Oct 1;35(21):1919-24. doi: 10.1097/BRS.0b013e3181d359bd.
• Lin GX, Akbary K, Kotheeranurak V, Quillo-Olvera J, Jo HJ, Yang XW, Mahatthanatrakul A, Kim JS. Clinical and Radiologic Outcomes of Direct Versus Indirect Decompression with Lumbar Interbody Fusion: A Matched-Pair Comparison Analysis. World Neurosurg. 2018 Nov;119:e898-e909. doi: 10.1016/j.wneu.2018.08.003. Epub 2018 Aug 10.
• Ozgur BM, Aryan HE, Pimenta L, Taylor WR. Extreme Lateral Interbody Fusion (XLIF): a novel surgical technique for anterior lumbar interbody fusion. Spine J. 2006 Jul-Aug;6(4):435-43. doi: 10.1016/j.spinee.2005.08.012.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Spine; Interbody Fusion; Decompression; Diskectomy
• Other Study ID Numbers: 02-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The medical records of the patients who participated in the study cannot be shared based on the protection of natural persons with regard to the processing of personal data according to the guidelines of the European Data Protection Board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No