| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|