| CTRI Number |
CTRI/2025/11/097277 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two different surgical procedures for cervical spine disease |
|
Scientific Title of Study
|
Clinical and radiological outcomes of stand-alone cage versus anterior plating in anterior cervical discectomy and fusion for cervical disc prolapse – A Comparative 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 |
Ramizbhai Memon |
| Designation |
MS orthopaedics Post graduate |
| Affiliation |
srm medical college hospital and research centre |
| Address |
2nd floor, Department of orthopaedics, srm medical college and hospital, kattankulathur,Chennai , Tamil Nadu,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9726264368 |
| Fax |
|
| Email |
Rrmemon2209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Anand B |
| Designation |
Head of department, professor, MS orthopaedics |
| Affiliation |
srm medical college hospital and research centre |
| Address |
2nd floor, G block , HOD Office room, Department of orthopaedics, srm medical college and hospital, kattankulathur,Chennai , Tamil Nadu,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
97909 63468 |
| Fax |
|
| Email |
vijayanb@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramizbhai Memon |
| Designation |
MS orthopaedics Post graduate |
| Affiliation |
srm medical college hospital and research centre |
| Address |
2nd floor, Department of orthopaedics, srm medical college and hospital, kattankulathur,Chennai , Tamil Nadu,
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9726264368 |
| Fax |
|
| Email |
Rrmemon2209@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ramizbhai Riyazbhai Memon |
| Address |
2nd floor, department of orthopaedic, srm medical college hospital and research centre, kattankulathur, Chennai, 603203 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ramizbhai Memon |
Srm medical college hospital and research centre |
2nd floor, department of orthopaedic, srm medical college hospital and research centre, kattankulathur, Tamil Nadu, 603203
Kancheepuram
TAMIL NADU |
9726264368
Rrmemon2209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srm medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M503||Other cervical disc degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anterior cervical discectomy and fusion(ACDF) with anterior cervical plate |
Anterior Cervical Discectomy and Fusion (ACDF) with Anterior Cervical Plate Fixation – The same anterior approach and decompression steps are performed. After placement of an interbody cage or bone graft within the disc space, an anterior cervical plate is applied and secured with screws to provide additional segmental fixation and stability. |
| Intervention |
Anterior cervical discectomy and fusion(ACDF) with Stand alone cage |
Anterior Cervical Discectomy and Fusion (ACDF) with Stand-Alone Cage – Standard anterior cervical approach is used. Following discectomy and decompression of the neural elements, an interbody stand-alone cage (PEEK or titanium) filled with autologous bone graft or bone substitute is inserted into the disc space. The cage’s integrated fixation screws provide primary stability without the use of an anterior cervical plate. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 yrs
MRI proven cervical disc prolapse with radiculopathy/ myelopathy
Failed conservative management for 3 months |
|
| ExclusionCriteria |
| Details |
Age less than 18yrs
history of trauma
history of infection
Previous surgery in the cervical spine
Inflammatory arthritis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Veterans RAND 12-Item (VR-12)
VAS pain score
Neck disability Index
|
2 weeks , 4 weeks , 3 months , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Intervertebral Level height
Subsidence of inter body device into superior and inferior endplates
Cervical lordosis
Segmental lordosis
Fusion With ct scan |
6 months-1 year |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 disc prolapse is common in adults under 50 years and may cause radiculopathy or myelopathy. When conservative management fails, Anterior Cervical Discectomy and Fusion (ACDF) is the preferred surgical procedure. Fusion can be achieved by either anterior cervical plating or a stand alone cage. Plating provides rigid fixation and reduces micromotion but carries risks of plate/screw failure and esophageal irritation. Stand alone cages minimize soft tissue retraction and are claimed to provide similar biomechanical stability. However, there is no consensus on which method offers superior clinical and radiological outcomes. This study aims to compare the two techniques. |