Protein and tissue changes in the ligamentum flavum in lumbar spinal stenosis
Official title: Proteomic and Histological Analysis of Ligamentum Flavum Hypertrophy and Degeneration in Lumbar Spinal Stenosis: Clinical, Surgical, and Therapeutic Implications
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07026552 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2028 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT07026552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.