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

NCT06719349 | Completed

• 1 other identifier: 02-2024
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Degeneration; Fusion of Spine (Disease)

Keywords

Spine; Decompression; Interbody Fusion; Diskectomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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 Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Single-segment L1-L4 spine discopathy.

You may not qualify if:

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

Sponsors & Collaborators

• Podkarpackie Oncological Center: lead

Study Sites (1)

Subcarpatian Oncology Centre

Brzozów, Podkarpackie Voivodeship, 38-500, Poland

Location

Related Publications (3)

• 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.

  PMID: 20671589 BACKGROUND

• 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.

  PMID: 30099187 BACKGROUND

• 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.

  PMID: 16825052 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Head of the Department of Orthopedics and Traumatology

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

PL (1)