| CTRI Number |
CTRI/2025/12/099846 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Effect of preserving normal neck attachments on movement and pain after spine surgery |
|
Scientific Title of Study
|
Evaluation of Clinical Outcomes of Preserving Versus Sacrificing C2 and C7 Spinous Process Attachments in Patients Undergoing Cervical Laminectomy: A Retrospective 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
|
| Stavya Spine Hospital and Research Institute,Near Nagri hospital,Mithakhali,Ellisbridge,Ahmedabad,380006. |
|
|
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
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 |
Both |
| Details |
1. More than or equal to 3 levels of cervical spinal stenosis and myelopathy
2. Preoperative modified Japanese Orthopedic Association (mJOA) scores of 8 – 14
3. Preoperative and postoperative imaging available (MRI, CT, or X-rays)
|
|
| ExclusionCriteria |
| Details |
A documented history of prior cervical spine surgery
Presence of congenital anomalies
Inflammatory arthropathies
History of cervical trauma
History of histologically proven cervical spinal tumor
Patients with less than 6 months follow up post operatively
Patients with incomplete pre operative or post operative data
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. mJOA score for neurological outcome
2. NDI score for functional disability
3. VAS score for pain
4. Operative parameters which included intra operative blood loss, operative time and post op complications
|
Follow up visits at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL. |
NIL. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 retrospective observational study will be
conducted in Stavya Spine Hospital and Research Institute, Ahmedabad enrolling
100 consecutive patients diagnosed with multilevel cervical stenosis and
myelopathy requiring C3-C6 or C3-C7 laminectomy. Patients will be randomly
allocated into two equal groups: Group A and Group B. Group A (n=50) underwent
modified muscle-preserving laminectomy with preservation of semispinalis
cervicis and nuchal ligament attachments at C2 and C7 spinous processes, while
Group B (n=50) underwent conventional laminectomy with complete detachment of
posterior muscle complex from C2 and C7. The study will include patients of
40-75 years of age with multilevel cervical stenosis (Greater or equal to 3 levels), preoperative modified
Japanese Orthopedic Association (mJOA) scores of 8-14, and minimum 6 month
follow up. Patients with previous cervical surgery, congenital anomalies,
inflammatory arthropathies, cervical trauma, malignancy and patients with
incomplete clinical and radiological records will be excluded from the study. |