Ossification of the ligamentum flavum
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Inclusion and Exclusion Criteria for Patients with Thoracic Ossification of Ligamentum Flavum (TOLF) Inclusion Criteria:Aged 18–75 years, regardless of gender. Diagnosed with TOLF independently by two senior physicians in our department based on clinical symptoms, physical signs, thoracic computed tomography (CT) three-dimensional reconstruction, and magnetic resonance imaging (MRI) findings; with clear surgical indications and no contraindications to surgery confirmed by preoperative examinations. (2) Inclusion and Exclusion Criteria for Control Patients without Ligament Ossification Inclusion Criteria:Aged 18–75 years, regardless of gender. No ossification of the posterior longitudinal ligament confirmed by preoperative thoracic CT three-dimensional reconstruction; TOLF diagnosis excluded by two senior physicians in our department; requiring thoracic posterior surgery for other diseases with clear surgical indications and no contraindications to surgery confirmed by preoperative examinations; and with ligamentum flavum tissue resected during surgery.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Spinal trauma, deformity, infection, or tumor;(2) A history of cervical spine surgery;(3) Complicated with bone metabolism-related diseases;(4) Complicated with rheumatic immune system diseases;(5) Patient refusal. Termination or Withdrawal Criteria (1) Subjects who are unwilling or unable to continue participating in the trial;(2) Subjects found to be ineligible for inclusion criteria or meet any of the exclusion criteria after enrollment;(3) Occurrence of intolerable adverse events or serious adverse events, and the investigator judges that the risks of continuing to participate in the study outweigh the benefits for the subjects;(4) Concurrent use of protocol-prohibited drugs or treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cobb angle;Piezo Type Mechanosensitive Ion Channel Component 1;Hematoxylin-Eosin staining;Bone Morphogenetic Protein 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vertebral angle;Ferguson angle;Osteocalcin;Runt-Related Transcription Factor 2;Osterix;Collagen Type I Alpha 1 Chain;SRY-Box Transcription Factor 9;Interleukin-1 Alpha;Interleukin-6; | — |
Countries
China
Contacts
Huashan Hospital, Fudan University