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OpenTrials
Completed

NCT Number: NCT06719349

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

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Key information

Conditions

Spine Degeneration Disease Fusion of Spine (Disease) Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Subcarpatian Oncology Centre

Brzozów, Podkarpackie Voivodeship, 38-500, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Single-segment L1-L4 spine discopathy.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. the quality of life

    Time frame: 3 months after the surgery

    the quality of life according to the EQ-VAS - Euro-Quality of Life Visual Analoque Score

  2. the functional status - Karnofsky scale

    Time frame: 3 months after the surgery

    patients' neurological status, functional status according to the Karnofsky scale

  3. the functional status Oswestry Disability Index

    Time frame: 3 months after the surgery

    patients' neurological status, functional status according to the ODI - Oswestry Disability Index

  4. the intensity of pain

    Time frame: 3 months after the surgery

    the intensity of pain according to the VAS - Visual AnalogueScale score

Secondary outcomes

  1. Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal

    Time frame: 3 months after the surgery

    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.

  2. Radiographic Outcomes: The Height and Width of the Intervertebral Foramina

    Time frame: 3 months after the surgery

    Based on pre- and postoperative MRI/RTG the following aspects were assessed: The Height and Width of the Intervertebral Foramina

  3. Radiographic Outcomes: lumbar segmental angle.

    Time frame: 3 months after the surgery

    Based on pre- and postoperative MRI/RTG the following aspects were assessed: lumbar segmental angle.

Sponsors and collaborators

Lead sponsor

Podkarpackie Oncological Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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