Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Recruiting now

Conditions studied: Spinal Stenosis of Lumbar Region, Spine Degeneration

In brief

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.

Key facts

Study ID

NCT07026552

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

100

Starts

2025-06-15

Expected to finish

2028-03-01

Last updated by the study team

2025-08-07

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiological (CT and/or MRI) and clinical evidence of lumbar spinal stenosis (LSS).
• Age range: 50-85 years.
• Signed informed consent, medical records release form, and HIPAA authorization form (or equivalent according to local regulations), reviewed and signed by the patient or legally authorized representatives.

You may not qualify if…

• Pediatric population and individuals under 50 years of age.
• Concomitant genetic musculoskeletal disorders.
• History of trauma.
• Spinal infections (spondylodiscitis, osteomyelitis, abscess, etc.).
• Presence of spinal tumors or other neoplasms.

Where it is running

• Fondazione Policlinico Agostino Gemelli IRCSS — Rome, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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