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CTRI Number  CTRI/2025/12/098897 [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   Retrospective 
Study Design  Other 
Public Title of Study   How Well Does a New Neck Surgery Method Work? A Study on Patient Recovery and X-ray Results 
Scientific Title of Study   Evaluation of Clinical and Radiological Outcomes of Anterior Cervical Hybrid Surgery. 
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 & Research Institute. 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Multi-level cervical spondylotic myelopathy/radiculopathy requiring hybrid surgery.
2. Failure of greater or equal to 6 weeks conservative therapy.
3. Ability to give informed consent.
 
 
ExclusionCriteria 
Details  1. Prior cervical spine surgery.
2. Active infection, trauma, tumor, inflammatory spine disease.
3. Severe osteoporosis.
4. Pregnancy.
5. Inability to comply with follow-up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Clinical: VAS for neck and arm pain, NDI, mJOA score, neurological examination.
2. Radiological: Cervical lordosis, segmental angle, ROM, implant position, fusion status, adjacent segment degeneration.
3. Surgical: Operative time, blood loss, hospital stay.
 		 follow-up at 6 weeks, 3 months, 6 months, 12 months, and annually up to 2 years. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL.  NIL. 
 
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)   23/12/2025 
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  

Cervical spondylotic myelopathy and radiculopathy are prevalent degenerative spine disorders affecting middle-aged and elderly individuals. Multi-level cervical spondylosis presents a unique challenge because traditional single-modality surgical approaches—such as multi-level anterior cervical discectomy and fusion (ACDF) or multi-level cervical disc arthroplasty (CDA)—may not provide optimal outcomes in all patients.

Hybrid surgery (HS), combining ACDF at some levels and CDA at adjacent levels, aims to balance motion preservation with stabilization. It may reduce adjacent segment degeneration, maintain cervical range of motion, and improve functional outcomes compared to multi-level fusion alone.

However, evidence regarding its long-term outcomes, radiological parameters, and complication rates remains limited, especially in multi-ethnic populations. This prospective study aims to systematically evaluate clinical, functional, and radiological outcomes following anterior cervical hybrid surgery in 200 patients.

 
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