| CTRI Number |
CTRI/2026/04/107683 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Neck Spine Operations in Patients with Spinal Cord Pressure:Is Nerve Monitoring Helpful? |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing Cervical Laminectomy with and without Intraoperative Neuromonitoring in Degenerative Cervical Myelopathy |
| Trial Acronym |
IONM-DCM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Rajasekaran |
| Designation |
Professor, Head of the Department |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Chairman and HOD office, First floor, B block, Ganga Hospital,313, Mettupalayam Road,
Saibaba colony, Coimbatore
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
08668173135 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Rajasekaran |
| Designation |
Professor, Head of the Department |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Chairman and HOD office, First floor, B block, Ganga Hospital,313, Mettupalayam Road,
Saibaba colony, Coimbatore
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
08668173135 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Rajasekaran |
| Designation |
Professor, Head of the Department |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Chairman and HOD office, First floor, B block, Ganga Hospital,313, Mettupalayam Road,
Saibaba colony, Coimbatore
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
08668173135 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga Orthopaedics Research and Education Foundation |
| Address |
SF No.442 Post, NGGO Colony, Vattamalaipalayam, Coimbatore, Tamil Nadu- 641022. |
| Type of Sponsor |
Other [Registered Trust, Darpan registration no-TN/2018/0191674] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gnanaprakash Gurusamy |
Ganga Hospital |
Spine department, B block, 313, Mettupalayam Road,
Saibaba colony 641043
Coimbatore
Coimbatore
TAMIL NADU |
08668173135
gnana395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board- Ganga Medical Centre and Hospitals pvt Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M471||Other spondylosis with myelopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical laminectomy with intraoperative neuromonitoring |
Patients will undergo posterior cervical laminectomy performed using standard surgical techniques. Continuous intraoperative neuromonitoring will be used throughout the procedure, including motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs), to assess spinal cord function in real time. Any significant changes in neuromonitoring signals will be addressed as per standard institutional protocols.
Duration-2 years |
| Comparator Agent |
Cervical laminectomy without intraoperative neuromonitoring |
Patients will undergo posterior cervical laminectomy using standard surgical techniques without the use of intraoperative neuromonitoring. Surgical decompression and intraoperative decision-making will be based on anatomical landmarks and standard clinical judgment. All other perioperative care will be similar to the intervention group.
Duration-2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (morethan 18 years)
Clinical diagnosis of degenerative cervical myelopathy
Radiological evidence of cervical spinal cord compression on MRI
Multilevel cervical stenosis (morethan 2 levels) requiring posterior decompression
Preserved or neutral cervical sagittal alignment
Planned for posterior cervical laminectomy
Ability to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Cervical kyphotic deformity requiring alternative surgical approach
Indication for combined anterior and posterior surgery
Prior cervical spine surgery
Non-degenerative pathology (trauma, infection, tumor, inflammatory disease)
Severe medical comorbidities precluding surgery
Patients unwilling or unable to provide informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
Postoperative neurological deterioration (new weakness or worsening of preoperative status)
|
Intraoperative: Neuromonitoring alerts, operative time, blood loss
Within 48 hours: Neurological status
At discharge: Neurological status
6 weeks: mJOA score
3 months: Neurological status and mJOA score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
Intraoperative neuromonitoring alerts (MEP/SEP)
Neurological complications (transient or persistent)
Functional outcome (mJOA score)
Operative time
Blood loss
Correlation between IONM changes and neurological recovery |
Intraoperative: Neuromonitoring alerts, operative time, blood loss
Within 48 hours: Neurological status
At discharge: Neurological status
6 weeks: mJOA score
3 months: Neurological status and mJOA score |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Degenerative cervical myelopathy (DCM) is a common cause of spinal cord dysfunction requiring surgical decompression. Posterior cervical laminectomy is a widely used procedure for multilevel disease. Intraoperative neuromonitoring (IONM) is often used to assess spinal cord function during surgery; however, its routine use remains variable, and its clinical benefit is not clearly established.
This prospective randomized controlled trial aims to compare postoperative neurological outcomes between patients undergoing cervical laminectomy with and without intraoperative neuromonitoring. A total of 100 patients will be enrolled and randomized into two groups. Outcomes assessed include postoperative neurological status, intraoperative neuromonitoring changes, functional recovery using mJOA score, complications, and perioperative parameters. The study aims to evaluate the clinical utility of intraoperative neuromonitoring in improving surgical outcomes in patients with degenerative cervical myelopathy. |