Protein and tissue changes in the ligamentum flavum in lumbar spinal stenosis
Proteomic and Histological Analysis of Ligamentum Flavum Hypertrophy and Degeneration in Lumbar Spinal Stenosis: Clinical, Surgical, and Therapeutic Implications
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07026552
This project will test whether specific protein and tissue changes in the thickened ligament behind the lower spine can be identified in people aged 50–85 having surgery for lumbar spinal stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT07026552 on ClinicalTrials.gov |
What this trial studies
This observational project will collect ligamentum flavum samples from patients aged 50–85 undergoing decompression surgery for lumbar spinal stenosis. Samples will be analyzed by mass spectrometry-based proteomics alongside detailed histological staining to characterize changes in elastic and collagen fibers. Researchers will correlate molecular signatures with preoperative imaging and intraoperative findings to link protein and tissue alterations with the pattern and severity of hypertrophy. The aim is to identify biomarkers and molecular pathways that could inform future diagnostics or targeted treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50–85 with clinical and radiologic evidence of lumbar spinal stenosis who consent to provide ligament tissue during planned surgical decompression.
Not a fit: Patients younger than 50, those with genetic musculoskeletal disorders, active spinal infection, tumors, prior trauma, or those not undergoing surgery are unlikely to benefit directly from this tissue-based research.
Why it matters
Potential benefit: If successful, the work could reveal molecular biomarkers and pathways that lead to earlier diagnosis or new targeted therapies for ligamentum flavum hypertrophy in lumbar stenosis.
How similar studies have performed: Histological studies have consistently shown elastin loss and increased collagen in hypertrophic ligamentum flavum, and a few small proteomic reports exist but no definitive molecular biomarkers have yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Rome, RM
- Fondazione Policlinico Agostino Gemelli IRCSS — Rome, RM, Italy (RECRUITING)
Study contacts
- Principal investigator: Giuseppe La Rocca — Fondazione Policlinico Agostino Gemelli IRCSS
- Study coordinator: Giuseppe La Rocca
- Email: giuseppe.larocca@policlinicogemelli.it
- Phone: + 39 3283776263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Stenosis of Lumbar Region, Spine Degeneration, Lumbar Spinal Stenosis, Ligamentum Flavum Hypertrophy, Proteomic Analysis, Molecular Biomarkers