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CTRI Number  CTRI/2024/12/078482 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Follow up study on safety and performance of distal humerus plate system 
Scientific Title of Study   A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Distal Humerus Plate System Intended for Fracture Fixation 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
CR_PMCF/P_28  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dinesh Chandra 
Designation  Director & Consultant 
Affiliation  Meerut Orthopaedics & Research Centre 
Address  Room No. 5, Department of Orthopedics R-120 (opp-water tank), Pallavpuram, Phase-ll, Meerut

Meerut
UTTAR PRADESH
250110
India 
Phone  7419660141  
Fax    
Email  drdineshchandra2024@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Private Limited 
Address  Room No. 2, Department of Clinical Research 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  Mr Gaurav Luthra 
Designation  Technical Director 
Affiliation  Auxein Medical Private Limited 
Address  Room No. 1 Department of Clinical Research 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, Sonipat-131028 Haryana, India 
 
Primary Sponsor  
Name  Auxein Medical Private Limited 
Address  Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate Kundli, Sonipat-131028 Haryana, India 
Type of Sponsor  Other [Medical device manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dinesh Cahndra  Meerut Orthopaedics & Research Centre  Room No. 5 Department of Orthopedics R-120 (opp-water tank), Pallavpuram, Phase-ll, Meerut-250110
Meerut
UTTAR PRADESH 		 8630267471

drdineshchandra2024@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Valentis Cancer Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S424||Fracture of lower end of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Distal humerus plate system  Intervention is intended to provide fixation of distal humerus fracture. The enrolled patients will be followed up at various time points till one year of surgery. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients presenting to Orthopaedic emergency/OPD with distal humerus fractures/ intercondylar humerus fracture. 
 
ExclusionCriteria 
Details  1. Infection, local or systemic, acute or chronic inflammation at the
operative site.
2. Patient with known history of metal allergy.
3. Mental illness or schizophrenic, which may cause patients to
ignore the limitations and precautions of the implanted material
leading to implants fracture and complication.
4. Patients having inadequate tissue coverage over the operative
site.
5. Presence of marked or rapid bone absorption, metabolic bone
disease, cancer, or any other tumor‐like condition of the bone
which may compromise fixation.
6. Female participant who is pregnant or planning pregnancy during
the course of the study.
7. Chronic alcoholics, and smokers.
8. Any condition or anatomy that makes treatment with the distal
humerus plate system infeasible.
9. Patients who are incarcerated or have pending incarceration. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Evaluation of function outcome scores (MEPS and Quick DASH).
2. Improvement in pain score (VAS).  		 Three time points; 3, 6, and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Radiological evaluation by X-ray radiographs to assess the mean time taken to achieve bone union.
2. Evaluation of any complications/adverse events associated with
implants. 		 Three time points; 3, 6, and 12 months. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   25/12/2024 
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   The proposed Post marketing clinical follow up study aims to assess the safety and performance of distal humerus plate system being manufactured by Auxein Medical Private Limited. A total of twenty patients of both gender with distal humerus fracture will be enrolled in the study, and will be followed up till one year post-operatively. The study includes assessment of functional outcome, pain scores, radiological evaluation of bone union, and recording and assessment of device associated adverse events.     
 
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