Actively Recruiting

Age: 50Years - 85Years
All Genders
NCT07026552

Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-07

100

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background Lumbar spinal stenosis (LSS) is a common condition characterized by spinal canal narrowing, often linked to ligamentum flavum hypertrophy (LFH) and degeneration. Fibrotic processes involving elastin and collagen alterations contribute to LF thickening and spinal instability. Despite progress, the molecular mechanisms underlying LFH remain unclear, necessitating targeted diagnostic and therapeutic strategies. Objective This study aims to analyze the proteomic and histological changes in LFH associated with LSS, correlating molecular signatures with imaging and surgical findings to identify potential therapeutic targets. Methods LF samples from LSS patients undergoing surgery will be analyzed using mass spectrometry-based proteomics and histology to identify biomarkers and molecular pathways. Correlations between imaging, intraoperative findings, and molecular profiles will be assessed. Expected Results The study aims to identify specific biomarkers and molecular pathways involved in LFH, linking them to clinical and imaging findings. Statistical analyses will evaluate associations between molecular alterations and surgical outcomes to define therapeutic targets. Significance By identifying molecular markers of LFH, this research aims to improve LSS diagnosis and treatment, potentially guiding targeted therapies to slow disease progression and enhance patient outcomes. Study Design A multidisciplinary team from Fondazione Policlinico Universitario Agostino Gemelli and Università Cattolica del Sacro Cuore will conduct the study, ensuring robust data integration and statistical evaluation. Conclusion This comprehensive study will provide valuable insights into the molecular and histological modifications associated with LFH in LSS, paving the way for new therapeutic approaches to improve patient outcomes and satisfaction.

CONDITIONS

Official Title

Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiological (CT and/or MRI) and clinical evidence of lumbar spinal stenosis (LSS).
  • Age between 50 and 85 years.
  • Signed informed consent, medical records release form, and HIPAA authorization form (or equivalent according to local regulations), signed by the patient or legally authorized representative.
Not Eligible

You will not qualify if you...

  • Under 50 years of age or pediatric population.
  • Presence of genetic musculoskeletal disorders.
  • History of trauma.
  • Spinal infections such as spondylodiscitis, osteomyelitis, or abscess.
  • Presence of spinal tumors or other neoplasms.

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Agostino Gemelli IRCSS

Rome, RM, Italy, 00168

Actively Recruiting

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Research Team

G

Giuseppe La Rocca

CONTACT

G

Gianluca Galieri

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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