Clinical trial NCT06478485: Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI
Official title: Feasibility and Clinical Applicability of Surgical Segments Choice for Laminoplasty in Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Modified K-line and Modified SC-line in MRI
Keywords: mK-line
mSC-line
Multilevel Cervical Spondylotic Myelopathy
Lead sponsor: Affiliated 2 Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-06-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators 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.

Brief 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.

Detailed description: This study intended to collect MRI of Patients with Multilevel Cervical Spondylotic Myelopathy. K-line(-) patients can be performed LAMP surgery for better prognosis if mK-line(+) and TypeⅠSC-line in MRI, but there are doubts on TypeⅡ and TypeⅢ. However, there has been no study that investigated the combination role of the mK-line and SC-line in surgical decision making for patients with MCSM. In this study, the investigators defined mK-line as a straight line connecting the midpoints of the anteroposterior canal diameter at cranial and caudal vertebrae of the open-door segment in MRI. Accordingly, the investigators propose a modified spinal cord line(mSC-line) that is a straight line connecting the postero-inferior point of the spinal cord at cranial and caudal vertebrae of the open-door segment in MRI, and simplify the mSC-line types into mSC-line(+) and mSC-line(-). In other words, mK-line and mSC-line in MRI are not fixed, but vary depending on the preoperative open-door segments. This study included patients with LAMP surgery for follow up, whose mK-line and mSC-line in MRI were double-positive for preoperative deciding open-door segments.

Eligibility criteria: 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 outcomes:
measure: sex
timeFrame: From 2020 to 2026
measure: age
timeFrame: From 2020 to 2026
measure: Japanese Orthopedic Association (JOA) score
timeFrame: From 2020 to 2026
measure: Visual Analog Scale (VAS) score
timeFrame: From 2020 to 2026
measure: Neck Disability Index(NDI) score
timeFrame: From 2020 to 2026
measure: Cobb angle
timeFrame: From 2020 to 2026
measure: Ishihara's Cervical Curvature Index(CCI)
timeFrame: From 2020 to 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: The Second Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Nantong University
name: Zhiming Cui, Professor
role: PRINCIPAL_INVESTIGATOR
References: