Clinical Trials in China / NCT06478485
Recruiting
Observational
Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI
NCT06478485 · tracked via the Priya Life Science China tracker
Condition(s) studied
Modified K-line and Modified SC-line in MRI
Investigational drug(s) / intervention(s)
No Intervention: MCSM
No Intervention: MCSM: No Intervention: MCSM
Study summary
This study intended to investigate the combined Impact of mK-line and mSC-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after LAMP.
Eligibility
Inclusion Criteria:
(1) Diagnosis of MCSM confirmed by two spine surgeons with MRI examination and clinic signs; (2) More than 2 level lesions and/or spinal stenosis in MRI, underwent LAMP surgery; (3) Available for both preoperative and follow-up imaging data and clinical data, including sex, age, clinical symptoms, Japanese Orthopedic Association (JOA) score, Visual Analog Scale (VAS) score, Neck Disability Index(NDI) score and MRI data.
Exclusion Criteria:
(1) Previous cervical spine surgery; (2) Diagnosis of tumor, central cord syndrome, infection or other acute traumatic injuries; (3) Diagnosed neurological disorders Parkinson's disease, polio, multiple sclerosis, or other central and peripheral nervous system diseases).
Primary outcome measure(s)
- sex — From 2020 to 2026
male or female - age — From 2020 to 2026
years old, no month or date - Japanese Orthopedic Association (JOA) score — From 2020 to 2026
The Japanese Orthopaedic Association (JOA) score is widely used to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Scoring details refer to the Japanese orthopaedic association score (JOA-score modified by Keller 1993) - Visual Analog Scale (VAS) score — From 2020 to 2026
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson.The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS can be presented in a way a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). Patients points the scores and the investigators recorded. - Neck Disability Index(NDI) score — From 2020 to 2026
The NDI can be scored as a raw score doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation. - Cobb angle — From 2020 to 2026
The Cobb angle is obtained by drawing parallel lines extending from the lower endplate of the most superior vertebral level (C2) and the lower endplate of the most inferior vertebral level (C7). - Ishihara's Cervical Curvature Index(CCI) — From 2020 to 2026
Ishihara's Cervical Curvature Index(CCI) = (a1 + a2 + a3 + a4)/L\*100, where a1 - 4 are the distances between the posterior margins of the inferior endplates of vertebral bodies and a line between the posterior aspects of the inferior endplates of C2 and C7(distance defined as L).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Nantong University | Nantong | Jiangsu | Recruiting |
More Affiliated 2 Hospital of Nantong University trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06478485 on ClinicalTrials.gov ↗ ← All trials in China