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CTRI Number  CTRI/2024/10/074836 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Treatment of cervical disorders with cervical plates and cages and to study improvement in cervical pain. 
Scientific Title of Study   A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Cervical System 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CR_PMCF/P_07, Version No.: 1.0, Dated: 21-12-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Private Limited 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419066141  
Fax    
Email  clinical2@auxeinmedical.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Private Limited 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419066141  
Fax    
Email  clinical2@auxeinmedical.com  
 
Details of Contact Person
Public Query  
Name  Mr Gaurav Luthra 
Designation  Technical Director 
Affiliation  Auxein Medical Private Limited 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  gaurav@auxeinmedical.com  
 
Source of Monetary or Material Support  
Auxein Medical Private Limited. Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli, Sonepat Haryana 131028, India. 
 
Primary Sponsor  
Name  Auxein Medical Private Limited 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli, Sonepat Haryana 131028, India. 
Type of Sponsor  Other [Medical device manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Abhishek Kashyap  MAMC & LNJP Hospital  Room No- 603, Department of Orthopedic Surgery, New Orthopedic Block, Maulana Azad Medical College & Associated Lok Nayak Hospital
New Delhi
DELHI 		 9716005800

drabhishekkashyap8@gmail.com 
Dr Bharat Dave  Stavya Spine Hospital and Research Institute  OPD room no. 4/5 2nd floor, Deparrtment of Orthopedics Ellis bridge, Near-Rashtrabhasha College, Mithakhali Ahmedabad-380006
Ahmadabad
GUJARAT 		 9825019913

brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC New Delhi  Submittted/Under Review 
Stavya Spine Hospital and Research Institute Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cervical plate and cage system  Study participants will be followed at 6 week, 6 month and 12 month. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients presenting to Orthopaedic OPD/emergency, requiring treatment with anterior cervical plate or/and cage.Specific indications include:
1. Single level tuberculosis
2. Cervical mylopathy
3. Tumor
4. Trauma
5. Single level degenerative disc disease
 
 
ExclusionCriteria 
Details  1. Patients with active local or systemic infection.
2. Patients with morbid obesity BMI more than 35 kg/m2.
3. Patients with mental disorders or currently on psychiatric treatment.
4. Alcoholics and or drug abusers.
5. Patients with metabolic bone disease.
6. Severe osteopenia
7. Metal sensitivity or allergies
8. Pregnant women or those planning pregnancy during study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Radiological evaluation by X - rays to calculate meantime to achieve
deformity correction/bone fusion.
2. Follow-up of the patient’s recovery by analyzing Visual analogue
scale (VAS) for pain assessment.  		 6 week, 6 month, and 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in quality of life through Neck disability index (NDI).
2. Evaluation of safety of device by record of any adverse event, serious
adverse event.  		 6 week, 6 month, and 12 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   16/10/2024 
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   This post marketing clinical follow up study is planned to evaluate the safety and performance of cervical plates and cages being manufactured by Auxein Medical Pvt Ltd. The Study plans to recruit a total of 60 patients from two centers. The total duration of study is two years including one year post-operative follow up of patients.
 
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