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CTRI Number  CTRI/2025/12/099013 [Registered on: 12/12/2025] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Comparing two types of neck surgeries over 5 years to find out which one helps patients more. 
Scientific Title of Study   A Five-Year Comparative Effectiveness Analysis of Anterior Cervical Discectomy and Fusion Versus Cervical Total Disc Replacement. 
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 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 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 Ellisbridge Mithakhali

GUJARAT
380006
India 
Phone  09825019913  
Fax    
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Second floor,Research Department ,Stavya Spine Hospital & Research Institute,Near Nagri hospital,Mithakhali,Ellisbridge,Ahmedabad,380006,Gujarat,India. 
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 ,Ellisbridge ,Mithakhali ,Ahmedabad GUJARAT 380006 India
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 
Comparator Agent  NIL.  NIL. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Symptomatic single level cervical disc prolapse / stenosis (C3 - C7).
Failed more than 6 weeks conservative management.
 
 
ExclusionCriteria 
Details  Revision surgeries
Infection
Neoplastic conditions
Multilevel disease.
Incomplete Clinical & Radiological records. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to follow-up in patient-reported pain and function and index-level motion, assessed by:
VAS –Neck pain (0–10) (primary pain measure)
Neck Disability Index (NDI; 0–100)
Nurick grade (0–5) 
Patient will be followed up at 3 months,
6 months and 12 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)   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  

Anterior cervical discectomy and fusion (ACDF) continue to be regarded as the benchmark surgical intervention for single-level cervical disc disease, particularly in patients presenting with radiculopathy, myelopathy, or combined myeloradiculopathy . The technique involves an anterolateral cervical approach for disc excision and interbody fusion, enabling effective neural decompression, restoration of cervical lordosis, maintenance of disc height, and provision of immediate segmental stability . Despite its proven clinical success, the obligatory segmental immobilization inherent to ACDF leads to altered cervical biomechanics and increased mechanical loading across adjacent motion segments .This predisposes patients to adjacent segment pathology, which encompasses adjacent segment degeneration (ASDeg)-radiological deterioration without clinical symptoms-and adjacent segment disease (ASDis), defined by symptomatic deterioration requiring clinical or surgical intervention.

Longitudinal clinical series have demonstrated that symptomatic ASDis develops at an estimated rate of nearly 2.9% per year, with approximately 25.6% (96/374) of patients expected to manifest new disease at an adjacent level within a decade following fusion. Radiographic degeneration is even more prevalent, with reported rates as high as 92% (266/288) on extended follow-up . Cervical total disc replacement (TDR) has emerged as a biomechanically advantageous, motion-preserving alternative that seeks to mitigate the drawbacks associated with fusion. By maintaining near-physiological segmental kinematics, TDR reduces compensatory hypermobility and stress transfer to adjacent segments while preserving motion at the operated level . Biomechanical investigations confirm that arthroplasty maintains segmental mobility and decreases adjacent-level motion compared with fusion. Clinical studies similarly report that TDR provides outcomes comparable to or better than ACDF in terms of pain relief, neurological improvement, functional recovery, and patient satisfaction, with lower secondary surgery rates (10/164 [6.1%] vs 24/189 [12.7%]) . Meta-analyses consistently demonstrate lower pooled rates of ASDeg following TDR (7-17%) relative to ACDF (25-33%), although differences in symptomatic ASDis and reoperation rates remain variable-likely attributable to heterogeneity in study design, follow-up duration, patient selection, and implant characteristics.

 

 
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