| CTRI Number |
CTRI/2025/12/098987 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to check if not cutting certain neck muscles during surgery improves recovery |
|
Scientific Title of Study
|
Does Preservation of C2 and C7 Spinous Process Attachments Improve Patient Outcomes in Cervical Laminectomy? A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Bharat R Dave |
Stavya Spine Hospital & Research Institute |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Ahmadabad
GUJARAT |
09825019913
brd_172@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL. |
NIL. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Multilevel cervical stenosis involving greater or equal to 3 consecutive levels
2. Symptomatic cervical myelopathy with clinical and radiological correlation
|
|
| ExclusionCriteria |
| Details |
1. Documented history of prior cervical spine surgery.
2. Congenital spinal anomalies.
3. Individuals with inflammatory arthropathies.
4. Individuals with a history of traumatic injury to the cervical spine.
5. Individuals with significant comorbidities that may interfere with treatment outcomes (e.g., severe osteoporosis, malignancies, or systemic inflammatory disorders).
6. Ossification of Posterior Longitudinal Ligament (OPLL) extending beyond C2 and/or C7.
7. Inability to comply with the follow up schedule.
8. Pathology extending beyond C2 and/or C7
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
mJOA scores (0-18): Assessed preoperatively and at 3, 6, 12, and 24 months postoperatively. JOA recovery rate calculated using: Recovery Rate (%) = [(Postoperative JOA - Preoperative JOA) / (17 - Preoperative JOA)] × 100.
Visual Analogue Scale (VAS) for axial neck pain : Measured at all time points, with 0 indicating no pain and 10 indicating worst imaginable pain.
Neck Disability Index (NDI) (0-50 scale or percentage): Assessed at all time points, evaluating functional disability related to neck pain.
Cervical Range of Motion (ROM) (degrees): Measured on dynamic lateral radiographs at 12 postoperatively.
|
Follow up visits at 3 months, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
C2-C7 Cobb angle (degrees): Measured on lateral cervical radiographs at preoperative baseline & 12 months postoperatively.
C2-C7 sagittal vertical axis (SVA) (mm): Measured on lateral cervical radiographs at baseline & 12 months.
Cervical lordosis maintenance: Assessed by comparing preoperative & postoperative Cobb angles.
Postoperative muscle cross-sectional area: Measured on T2-weighted MRI at 12 months comparing multifidus & semispinalis cervicis areas between groups.
|
Follow up visits at 3 months, 6 months & 1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
24/12/2025 |
| 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) |
Open to Recruitment |
|
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
|
This prospective observational comparative study will be conducted at
Stavya Spine Hospital and Research Institute, Ahmedabad. The study enrolled 200
consecutive patients diagnosed with multilevel cervical spondylotic myelopathy
(CSM) requiring cervical laminectomy at C3-C6 or C3-C7 levels. Patients will be
prospectively distributed into two equal groups based on the surgical technique
employed at the time of surgery: Group A (Preservation Group,
n=100) which will undergo modified muscle-preserving laminectomy with
preservation of semispinalis cervicis and nuchal ligament attachments at C2 and
C7 spinous processes, while Group B (Conventional Group, n=100) will
undergo conventional laminectomy with complete detachment of the posterior
muscle complex from C2 and C7 spinous processes. Written informed consent was
obtained from all participants prior to surgery. |