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

Completed

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

• Registration Number: NCT06719349
• Lead Sponsor: Podkarpackie Oncological Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Single-segment L1-L4 spine discopathy.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal	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.
Radiographic Outcomes: The Height and Width of the Intervertebral Foramina	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
Radiographic Outcomes: lumbar segmental angle.	3 months after the surgery	Based on pre- and postoperative MRI/RTG the following aspects were assessed: lumbar segmental angle.

Trial Locations

Locations (1)

Subcarpatian Oncology Centre; 🇵🇱 Brzozów, Podkarpackie, Poland