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CTRI Number  CTRI/2024/07/071664 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To study performance of humerus nail in bone union in patients with humerus fracture. 
Scientific Title of Study   A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Humerus Nailing System intended for Fracture Fixation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CR_PMCF/P_04, Version 1.0, Issue Date: 5-Jan-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahipatsinh Parmar 
Designation  Senior Orthopedic Consultant 
Affiliation  Hi-tech Multispeciality Hospital 
Address  Room No. 5, Department of Orthopedics, Hi-tech Multispeciality Hospital, 1180 - Sector 3D GH road Near Gh 11/2 Bus stand, Gandhinagar

Gandhinagar
GUJARAT
382003
India 
Phone  9825031329  
Fax    
Email  mahipatparmar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Aslam 
Designation  Clinical Research Manager 
Affiliation  Auxein Medical Private Limited 
Address  Room No. 1, Department of Clinical Research, Auxein Medical Private Limited. 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 Private Limited 
Address  Room No. 1, Department of Clinical Research, Auxein Medical Private Limited. Plot Number 168 ‐169‐170 Phase IV, HSIIDC, Industrial Estate, Kundli


HARYANA
131028
India 
Phone  7419660141  
Fax    
Email  clinical2@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 [Orthopedic Implant 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 Mahipatsinh Parmar  Hi-tech Multispeciality Hospital  Room No. 7, GF, Department of Orthopedics Plot no 1180- Sector 3D GH road Near Gh 11/2 Bus stand Gandhinagar 382003
Gandhinagar
GUJARAT 		 9825031329

mahipatparmar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hi Tech Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S423||Fracture of shaft of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Humerus nailing  Total duration of intervention is one year 
Comparator Agent  There is no comparator agent in the study.  This is a single arm study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients presenting to Orthopaedic emergency/ OPD with Humerus shaft fracture will be included in the study. 
 
ExclusionCriteria 
Details  1. Infection, local or Systemic Acute or Chronic Inflammation to the operative site.
2. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure complications such as known active cancer, neuromuscular disorder etc.
3. In case subject has inadequate tissue coverage of the operative site.
4. Subjects with Symptomatic Arthritis.
5. Subjects with Suspected or documented metal allergy or intolerance.
6. Subjects with substance abuse/alcohol issues.
7. Subjects who are incarcerated or have pending incarceration.
8. Female participant who is pregnant or planning pregnancy during the course of the study.
9. Fracture that are not amenable to humerus nailing technique.
10. Any patient unwilling to cooperate with the post-operative instructions.
11. Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
12. Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.
13. Implant utilization that would interfere with anatomical structures or physiological performance.

 
 
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-ray radiographs to calculate mean time to achieve bone fusion and deformity correction or stabilization.
2. Quality of movement in arm and shoulder by calculating DASH score.
 		 Follwo up at 6 week, 3 month, 6 month, and 12 month  
 
Secondary Outcome  
Outcome  TimePoints 
1. Analyzing Visual analogue score (VAS) for pain assessment.
2. Any adverse event or serious adverse event during follow up, especially the one mentioned in the Product Description.
 		 6 weeks, 3, 6, and 12 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) 16/03/2027 
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  

Humerus nailing system is intended to provide fixation to diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension and impending pathologic fractures. As a manufacturer, Auxein Medical Pvt Ltd has planned to conduct a Post-marketing clinical follow-up (PMCF) study following the CE marking of the device (Humerus Nailing System) marketed for its intended use and aims to verify the clinical performance and safety of the implant. The study involves one year post-operative follow-up to update the clinical performance and outcome of our device. This PMCF is required by the regulatory authorities for all medical device implants that do not have medium to long-term clinical evidence available at the time of gaining approval to market.

 
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