| CTRI Number |
CTRI/2025/12/098899 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Using Multiple Rods to Improve Stability in Upper Neck Fusion Surgery |
|
Scientific Title of Study
|
Multiple-Rod Construct for Occipito-Cervical Fusion: 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
|
|
|
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: M50||Cervical disc disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing occipito-cervical fusion with a multiple-rod construct.
2. Complete clinical records and imaging available.
3. Minimum follow-up Greater than or equal to 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Incomplete clinical or radiological data.
2. Lost to follow-up before 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analog scale (VAS)
Neck Disability Index (NDI)
Modified Japanese orthopaedic association scale (mJOA)
Nurick Grade
|
Patients will be followed up after 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL. |
NIL. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2025 |
| 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)
Modification(s)
|
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
|
Occipitocervical
fusion is a well-established procedure for managing craniovertebral junction
(CVJ) anomalies, including basilar invagination (BI) and irreducible
atlanto-axial dislocation (AAD). The complex anatomy and biomechanics of the
CVJ require rigid internal fixation for adequate stability, early mobilization,
and successful fusion.
Surgical
techniques have evolved from non-instrumented bone grafting with halo
immobilization to modern screw-rod constructs, improving rigidity and outcomes.
Advances such as intraoperative 3D imaging and navigation have increased screw
placement accuracy while minimizing neurovascular risks.
C2
vertebra offers multiple anchorage points (pedicle, pars, lamina). Dual or
multiple-rod constructs from C2 to occiput may enhance biomechanical stability
and fusion surface area. Literature on multiple-rod constructs for CVJ fixation
remains limited. This study retrospectively evaluates 10 patients who underwent
occipito-cervical fusion using a multiple-rod construct. |