Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Histological Modifications in the Ligamentum Flavum in Lumbar Spinal Stenosis and Other Degenerative Spinal Diseases — Intraoperative sample collection and subsequent laboratory analysis within 12 months post-surgery
  This outcome measures the relative abundance and structural organization of collagen and elastin fibers in ligamentum flavum tissue from patients with lumbar spinal stenosis and other degenerative spinal diseases, using histological staining. Unit of Measure: Histological score or percentage composition
• Cellularity of Ligamentum Flavum Tissue — Intraoperative sample collection; analysis completed within 12 months post-surgery
  This outcome measures the number and density of fibroblasts and other resident cells in the ligamentum flavum. Unit of Measure: Cells per high power field (HPF)
• Presence of Inflammatory Markers in Ligamentum Flavum — Intraoperative sample collection; analysis completed within 12 months post-surgery
  This outcome evaluates the expression of inflammatory markers (e.g., TNF-α, IL-6, CD68) in ligamentum flavum tissue using immunohistochemistry or immunofluorescence. Unit of Measure: Semi-quantitative histological score or intensity of staining

Trial sites (1)

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