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Clinical Trials/NCT06719349
NCT06719349
Completed
Not Applicable

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

Podkarpackie Oncological Center1 site in 1 country38 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spine Degeneration
Sponsor
Podkarpackie Oncological Center
Enrollment
38
Locations
1
Primary Endpoint
the quality of life
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Podkarpackie Oncological Center
Responsible Party
Principal Investigator
Principal Investigator

Grzegorz Guzik

PhD, MD, Head of the Department of Orthopedics and Traumatology

Podkarpackie Oncological Center

Eligibility Criteria

Inclusion Criteria

  • Single-segment L1-L4 spine discopathy.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

the functional status - Karnofsky scale

Time Frame: 3 months after the surgery

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

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

the intensity of pain

Time Frame: 3 months after the surgery

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

Secondary Outcomes

  • Radiographic Outcomes: The Cross-Sectional Area of the Spinal Canal(3 months after the surgery)
  • Radiographic Outcomes: The Height and Width of the Intervertebral Foramina(3 months after the surgery)
  • Radiographic Outcomes: lumbar segmental angle.(3 months after the surgery)

Study Sites (1)

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