Modified K-line and Modified SC-line in MRINCT06478485
Laminoplasty for Multilevel Cervical Spondylotic Myelopathy Guided by Modified K-line and Modified SC-line in MRI
An observational study of Modified K-line and Modified SC-line in MRI, run by Affiliated 2 Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Modified K-line and Modified SC-line in MRI
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Chunshuai Wu, Doctor, +8613861989196, wcsspine@ntu.edu.cn
About this study
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
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.
Read the 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.
- Being tested
- No Intervention: MCSM
- Keywords
- mK-line, mSC-line, Multilevel Cervical Spondylotic Myelopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: MCSMDiagnostic test
No Intervention: MCSM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: No Intervention: MCSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
sex
male or female
Measured: From 2020 to 2026
age
years old, no month or date
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From 2020 to 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jan 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified K-line and Modified SC-line in MRIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated 2 Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
- Investigators
- Zhiming Cui, Professor, Principal investigator, Second Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478485
- Sponsor's protocol ID
- mK-line and mSC-line
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06478485
- Acronym / sponsor ID
- mK-line and mSC-line
- Keywords
- mK-line, mSC-line, Multilevel Cervical Spondylotic Myelopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated 2 Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCSM | – | Diagnostic Test: No Intervention: MCSMThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: MCSMNo Intervention: MCSM | Diagnostic test | MCSM |
Primary outcome
sex
Time frame: From 2020 to 2026
male or female
age
Time frame: From 2020 to 2026
years old, no month or date
Japanese Orthopedic Association (JOA) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiming Cui, Professor principal investigator
Second Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Modified K-line and Modified SC-line in MRI, run by Affiliated 2 Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunshuai Wu, Doctor (+8613861989196, wcsspine@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sex (time frame: From 2020 to 2026). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.