Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pediatric population and individuals under 50 years of age.
Concomitant genetic musculoskeletal disorders.
History of trauma.
Spinal infections (spondylodiscitis, osteomyelitis, abscess, etc.).
Trial population
The study population will consist of adult patients (aged 50-85 years) undergoing spinal surgery at the Fondazione Policlinico A. Gemelli IRCCS, a tertiary referral center specializing in neurosurgical care. Patients will be evaluated, assessed for surgical indication, and enrolled in the study at the Neurosurgery Department of the Institution.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Lumbar Spinal Stenosis Surgery Group
Group B: Other Degenerative Spinal Disease Surgery Group
Trial outcomes
Primary outcomes
1
Histological Modifications in the Ligamentum Flavum in Lumbar Spinal Stenosis and Other Degenerative Spinal Diseases
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
Time frame
Intraoperative sample collection and subsequent laboratory analysis within 12 months post-surgery2
Cellularity of Ligamentum Flavum Tissue
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)
Time frame
Intraoperative sample collection; analysis completed within 12 months post-surgery3
Presence of Inflammatory Markers in Ligamentum Flavum
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
Time frame
Intraoperative sample collection; analysis completed within 12 months post-surgerySecondary outcomes
1
Expression of Matrix Metalloproteinases (MMPs) in Ligamentum Flavum Tissue
This outcome quantifies the expression of specific MMPs (e.g., MMP-2, MMP-9) involved in extracellular matrix remodeling in hypertrophied ligamentum flavum. Unit of Measure: Relative expression (e.g., fold-change via qPCR or densitometric units via Western blot)
Time frame
Within 12 months post-surgery, based on sample processing and analysis.2
Expression of Transforming Growth Factor-beta (TGF-β) in Ligamentum Flavum Tissue
This outcome evaluates the expression of TGF-β, a key mediator in fibrosis and hypertrophy. Unit of Measure: Relative expression (e.g., immunohistochemistry score, qPCR fold-change)
Time frame
Intraoperative tissue collection; laboratory analysis within 12 months post-surgery3
Expression of Bone Morphogenetic Proteins (BMPs) in Ligamentum Flavum Tissue
This outcome investigates the expression of BMPs (e.g., BMP-2, BMP-7) which are implicated in osteogenic changes and fibrosis. Unit of Measure: Relative expression (e.g., fold-change via qPCR or immunohistochemistry score)
Time frame
Intraoperative tissue collection; laboratory analysis within 12 months post-surgery4
Correlation Between Histological and Molecular Findings and Preoperative Clinical Presentation
This outcome assesses the relationship between tissue-based findings and clinical parameters such as pain, disability, and imaging severity. Unit of Measure: Correlation coefficient (e.g., Pearson's r or Spearman's ρ)
Time frame
Preoperative clinical data and intraoperative sample analysis; correlation analysis within 12 monthsSponsors and contacts
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Source ClinicalTrials.gov