Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Modified K-line and Modified SC-line in MRI
• Intervention / Treatment: Diagnostic test: No Intervention: MCSM

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Chunshuai Wu, Doctor; Phone Number: +8613861989196; Email: wcsspine@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • The Second Affiliated Hospital of Nantong University
      • Contact: Chunshuai Wu, Doctor; Phone Number: +8613861989196; Email: wcsspine@ntu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

MCSM; This study collected MRI images and baseline information of patients with multilevel cervical spondylotic myelopathy (MCSM) and underwent Laminoplasty (LAMP) surgery in Nantong First People's Hospital. No interventions would be used. This study just collect the MRI images pre- or postoperation to investigate the effect of the combination 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.

Diagnostic test: No Intervention: MCSM; No Intervention: MCSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sex	male or female	From 2020 to 2026
age	years old, no month or date	From 2020 to 2026
Japanese Orthopedic Association (JOA) score	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)	From 2020 to 2026
Neck Disability Index(NDI) score	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.	From 2020 to 2026
Cobb angle	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).	From 2020 to 2026
Ishihara's Cervical Curvature Index(CCI)	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).	From 2020 to 2026
Visual Analog Scale (VAS) score	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.	From 2020 to 2026

Collaborators and Investigators

• Sponsor: Affiliated 2 Hospital of Nantong University
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Zhiming Cui, Professor, Second Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: mK-line; mSC-line; Multilevel Cervical Spondylotic Myelopathy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: mK-line and mSC-line

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No