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CTRI Number  CTRI/2024/07/070241 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the safety and performance of facial bone plates and time taken in bone union.  
Scientific Title of Study   A Prospective, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Craniomaxillofacial Plate System 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CR_PMCF/P_03, Version: 1.0, Date: 05.01.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gursimrat Singh 
Designation  Director & Consultant 
Affiliation  Cheema Hospital and Trauma Center  
Address  Room no. 2, Ground Floor, Department of Orthopedics, Cheema Hospital and Trauma Center, Kichha Road, Bigbara, Rudrapur

Udham Singh Nagar
UTTARANCHAL
263153
India 
Phone  9639069009  
Fax    
Email  drgscheema@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Pvt Ltd 
Address  First floor, Clinical Research Department, Auxein Medical Pvt Ltd Plot Number 168 ‐169‐170, Phase IV, HSIIDC, Industrial Estate, Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  clinical2@auxeinmedical.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Pvt Ltd 
Address  First floor, Clinical Research Department, Auxein Medical Pvt Ltd Plot Number 168 ‐169‐170, Phase IV, HSIIDC, Industrial Estate, Kundli

Sonipat
HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  clinical2@auxeinmedical.com  
 
Source of Monetary or Material Support  
Auxein Medical Pvt Ltd Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate, Kundli, Sonepat Haryana 131028 
 
Primary Sponsor  
Name  Auxein Medical Pvt Ltd 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate, Kundli, Sonepat Haryana 
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gursimrat Singh  Cheema Hospital and Trauma Center  Room no. 2, Department of Orthopedics, Kichha Road, Bigbara, Rudrapur, U.S Nagar, Uttarakhand -263153 India
Udham Singh Nagar
UTTARANCHAL 		 9639069009

drgscheema@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Craniomaxillocofacial (CMF) plates and screws for fixation of facial bone deformity and fractures   CMF plates and screws will be used for fixation of facial bones. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or Female, aged 18 - 75 years.
2. Patients presenting emergency/OPD requiring fixation of CMF fracture. 
 
ExclusionCriteria 
Details  1. Subjects with a disease entity or condition that could hinder bone healing
and create unacceptable risk of fixation failure or complications such as
known active cancer, neuromuscular disorder.
2. Subjects with metabolic bone disease.
3. Subject with inadequate tissue coverage of the operative site.
4. Subjects with substance abuse/alcoholics.
5. Subjects who are incarcerated or have pending incarceration.
6. Female participant who is pregnant or planning pregnancy during the
study.
7. Morbid obesity. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Bone healing and union
2 Improvement in QOL 		 6 week
3 month
6 month and 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
Recording of AEs SAEs  6 week
3 month
6 month and 12 month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2024 
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   Assessing the functional and aesthetic outcomes of craniomaxillofacial reconstruction is essential for evaluating the success of treatment interventions. Outcome measures, such as patient-reported outcomes, quality of life assessments, and objective functional evaluations, provide valuable insights into the effectiveness of various surgical approaches and techniques. Long-term follow-up is necessary to monitor for potential complications, such as implant failures, infections, or late sequelae, and address them promptly. Craniomaxillofacial trauma requires a comprehensive and multidisciplinary approach for evaluation, management, and reconstruction. By collaborating among various specialists, leveraging technological advancements, and emphasizing long-term follow-up, healthcare professionals can optimize patient outcomes and minimize complications in craniomaxillofacial trauma. Present post marketing clinical follow up study aims to evaluate the safety and performance of craniomaxillofacial plates and screws manufactured by Auxein Medical Pvt Ltd. 
 
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