Actively Recruiting
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
Eligibility Criteria
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.
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
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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