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

NCT ID: NCT06478485

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2027-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Modified K-line and Modified SC-line in MRI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No Intervention: MCSM

Intervention Type DIAGNOSTIC_TEST

No Intervention: MCSM

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention: MCSM

No Intervention: MCSM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Affiliated 2 Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiawei Jiang

Department of spine surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhiming Cui, Professor

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nantong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chunshuai Wu, Doctor

Role: CONTACT

+8613861989196

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chunshuai Wu, Doctor

Role: primary

+8613861989196

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

mK-line and mSC-line

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cervical Spondylotic Myelopathy Surgical Trial
NCT02076113 ACTIVE_NOT_RECRUITING NA