| CTRI Number |
CTRI/2026/04/107688 [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 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 |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof 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, 314, Mettupalayam Road, Saibaba colony, Coimbatore-641043
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9843022325 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof SRajasekaran |
| Designation |
Professor, Head of the Department |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Chairman and Hod office, first floor, Block, Ganga Hospital, 314, Mettupalayam Road, Saibaba colony, Coimbatore-641043
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9843022325 |
| Fax |
|
| Email |
rajasekaran.orth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof SRajasekaran |
| Designation |
Professor, Head of the Department |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
hairman and Hod office, first floor, Block, Ganga Hospital, 314, Mettupalayam Road, Saibaba colony, Coimbatore-641043
Saibaba colony
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9843022325 |
| 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
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, (2) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Posterior cervical enbloc laminectomy and instrumentation |
Posterior cervical decompression will be performed by enbloc laminectomy at the clinically and radiologically involved levels. Posterior instrumented fusion will be done using lateral mass screws and rods (and C7 pedicle screws where appropriate). The procedure will be performed under general anaesthesia in prone position with head fixation. Standard peri-operative antibiotics and postoperative rehabilitation will be followed as per institutional protocol. |
| Comparator Agent |
Posterior cervical piecemeal laminectomy and instrumentation |
Posterior cervical decompression will be performed by laminectomy at the clinically and radiologically involved levels. Posterior instrumented fusion will be done using lateral mass screws and rods (and C7 pedicle screws where appropriate). The procedure will be performed under general anaesthesia in prone position with head fixation. Standard peri-operative antibiotics and postoperative rehabilitation will be followed as per institutional protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients more than 18 years of age,
Clinical diagnosis of cervical myelopathy,
Multilevel involvement - more than 2 levels requiring posterior decompression,
Neuutral or lordotic cervical spine,
Ability to provide written informed consent |
|
| ExclusionCriteria |
| Details |
-cervical kyphosis
-Conditions requiring anterior and posterior surgery
-Previous cervical spine surgery
- Trauma, infection, tumor, or inflammatory spinal disease |
|
|
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 |
| To compare the intraoperative neuromonitoring responses, specifically motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs), between en bloc and piecemeal laminectomy techniques in patients undergoing surgery for cervical spondylotic myelopathy, with respect to the incidence of signal improvement, deterioration, or no change during decompression. |
preop, immediate postop, 24 hours, 48 hours, 72 hours, 3 months, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3.2.Secondary objectives (if any):
· To compare the incidence of intraoperative and postoperative neurological complications, including transient or persistent neurological worsening, between the two groups.
· To assess and compare clinical neurological outcomes using the modified Japanese Orthopaedic Association (mJOA) score at follow-up.
· To compare the incidence of dural tear and postoperative cerebrospinal fluid leakage, operating time, and blood loss between en bloc and piecemeal laminectomy techniques.
· To analyze the relationship between intraoperative neuromonitoring changes and postoperative neurological recovery in patients undergoing posterior cervical decompression. |
preop, immediate postop, 24 hours, 48 hours, 72 hours, 3 months, 6 months, 1 year |
|
|
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="1"
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 in patients with progressive neurological deficits. Posterior cervical laminectomy is widely used for multilevel disease and can be performed using either en bloc or piecemeal techniques. While en bloc laminectomy provides rapid decompression, it may result in sudden spinal cord expansion and intraoperative neuromonitoring changes. In contrast, piecemeal laminectomy allows gradual decompression and may reduce intraoperative neural stress. There is limited prospective randomized evidence comparing these two techniques. This study is a single-center randomized controlled trial designed to compare intraoperative neuromonitoring responses (MEPs and SEPs), perioperative parameters, and clinical outcomes between en bloc and piecemeal laminectomy in patients with cervical spondylotic myelopathy. A total of 100 patients will be enrolled and randomized into two groups. The primary outcome is intraoperative neuromonitoring changes, while secondary outcomes include neurological recovery (mJOA score), complications, operative time, and blood loss. The findings of this study aim to provide evidence to guide surgical decision-making and improve patient outcomes in cervical myelopathy. |