Lumbar disc herniation
Conditions
Interventions
Gold Standard:Paraffin pathology examination (Hematoxylin and Eosin staining)
Index test:EndoSCell® Cell-Level Fluorescence-Guided Imaging System
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–70 years, any gender. 2.Preoperatively diagnosed with single-level, primary lumbar disc herniation, and scheduled for simple minimally invasive lumbar discectomy (e.g., endoscopic PTED/UBE or microdiscectomy MIS) according to routine clinical management. 3.Participants voluntarily sign the informed consent form and agree to participate in the study. 4.The study samples are remnant/discarded ex vivo nucleus pulposus tissue samples left over after excision during routine clinical care and no longer required for clinical diagnosis and treatment. 5.Basic clinical data and routine preoperative imaging data corresponding to the samples are available for research analysis. 6.After coding and de-identification, the samples can be used for EndoSCell scanning and corresponding paraffin pathology analysis.
Exclusion criteria
Exclusion criteria: 1.Concomitant obvious lumbar instability, spondylolisthesis, or requirement for fusion surgery. 2. History of previous lumbar surgery at the target level. 3.Severe osteoporosis (DXA T-score <= -3.5). 4.Concurrent spinal infection, tumor, fracture, or inflammatory disease. 5.Severe spinal deformity that may interfere with standardized intraoperative sample collection. 6.Pregnancy or lactation. 7.Judged by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance and concordance of EndoSCell in evaluating degeneration of ex vivo nucleus pulposus tissue; | — |
Secondary
| Measure | Time frame |
|---|---|
| Agreement between ES-NDG grading and pathological grading (Kappa value);Distribution characteristics of nucleus pulposus degeneration among different testing units from the same case;Correlation between preoperative MRI Pfirrmann grading and EndoSCell grading or HE pathological grading; | — |
Countries
China
Contacts
Public ContactFei Zou
Huashan Hospital, Fudan University
Outcome results
None listed