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CTRI Number  CTRI/2022/10/046936 [Registered on: 31/10/2022] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Tibia bone related fracture fixation study  
Scientific Title of Study   Post Marketing Clinical Follow-up Study, a single arm prospective case series to evaluate the safety and effectiveness of Intramedullary Tibia Nailing system intended for Tibia bone related fracture fixation (PMCF-INITIA NAIL)  
Trial Acronym  PMCF-INITIA NAIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinay Gupta 
Designation  Senior Consultant Orthopedics 
Affiliation  Eternal Hospital, A Unit of Eternal Heart Care Center & Research Institute 
Address  Eternal Hospital, A Unit of Eternal Heart Care Center & Research Institute Private Limited, 3 A ,Jagatpura Road, Near Jawahar Circle, Jaipur

Jaipur
RAJASTHAN
302017
India 
Phone    
Fax    
Email  vinaygupta.tnmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lokesh Chauhan 
Designation  Clinical Research Manager 
Affiliation  Kaulmed Private Limited 
Address  Kaulmed Private Limited Plot no 157, Phase V, HSIIDC, Kundli Industrial Area, Sec-56, Sonipat

Sonipat
HARYANA
131028
India 
Phone    
Fax    
Email  lokesh.chauhan@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Luthra 
Designation  Technical Director 
Affiliation  Kaulmed Private Limited 
Address  Kaulmed Private Limited Plot no 157, Phase V, HSIIDC, Kundli Industrial Area, Sec-56, Sonipat

Sonipat
HARYANA
131028
India 
Phone    
Fax    
Email  gaurav@kaulmed.com  
 
Source of Monetary or Material Support  
Eternal Hospital, Jaipur, Rajasthan 
KAULMED Private Limited, Sonipat, Haryana 
 
Primary Sponsor  
Name  Kaulmed Pvt. Ltd. 
Address  Kaulmed Private Limited Plot no 157, Phase V, HSIIDC, Kundli Industrial Area, Sec-56, Sonipat, Haryana -131028 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aseem Gupta  Akhila Hospital, Jaipur  Akhila Hospital, Paldi Meena, Agra Road Jaipur-303012
Jaipur
RAJASTHAN 
9460555573

aseemgupta1978@gmail.com 
Dr Vinay Gupta  Eternal Hospital, A unit of Eternal Heart Care Center & research Institute Private Limited  3A, Jagatpura Road, Near Jawahar Circle, Jaipur
Jaipur
RAJASTHAN 
7665075430

vinaygupta.tnmc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Eternal Heart Care and Research institute- Institutional Ethics Committee  Approved 
Eternal Heart Care 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: V00-Y99||External causes of morbidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Tibia Nailing System  Intended for fracture fixation of Tibia bone; Single use device for more than 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subject is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 years or above, skeletally mature patient.
3. Subject is willing and able to complete required study visits or assessments.
4. Subject diagnosed as per indications. 
 
ExclusionCriteria 
Details  1. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
2. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC)
3. Subjects unwilling to sign the Informed Consent document.
4. Subjects who are incarcerated or have pending incarceration.
5. Female participant who is pregnant or planning pregnancy during the course of the study.
6. Fracture that are not amenable to intramedullary tibia nailing technique
7. Morbid obesity (BMI (Kg/m2)) > 35 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of functional performance from baseline to last follow up by recording the Lower extremity functional score (LEFS).  Visit - Screening, 1, 2, 3, 4 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Safety of Device by record of any adverse event, serious adverse event and complication during follow up, especially the one mentioned in the Instruction of Use. (IFU)   Visit - Pre-surgery, Post-surgery, 1, 2, 3, 4 
Follow-up of the patient’s recovery by a analysing Visual analogue score (VAS) for pain assessment.  Visit - Screening, Pre-surgery, Post-surgery, 1, 2, 3, 4 
Radiologic Evaluation (X-Ray)   Screening, Pre-surgery, Post-surgery, 1,2,3,4 
Assessment Quality of Life (QOL) by SF-12  Screening, 1, 2, 3, 4 
Duration of Hospital stay, Revision rate (Removal of any Component), Re-operation Rate.  12 Months 
Mortality.  12 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/11/2022 
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   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The most common and major fractured bone in the leg is considered to be a tibia bone. The fracture can lead to long hospital stay and can affect the life of the patient socially, mentally and professionally as well. Because of many factors , these injuries are not easy to manage. These factors includes limited soft tissue cover, poor vascularity of the injured area. The most recognized complications includes infection, mal-union, and non-union (Achten et al., 2015). Intramedullary nailing is considered as the gold standard of care for tibia shaft fracture. This is so because it helps in the reduction of surgical insult to the fractured and soft tissue (Attal et al., 2012).The incidence of tibia fracture has been varied from years across different countries and culture. One study has concluded that males have highest rate of incidence which is recorded as 21.5/1000000/year when compared with the rate of women. The highest frequency of fractures lies between the age of 10-20 years (Larsen et al., 2015). According to AO classification, the most common type of fracture recorded was type 42-A1 which constitutes of 34% of total tibial shaft fracture (Larsen et al., 2015).

There are many techniques which are used for the operative management of the fractures. These techniques includes intra-medullary implants, half-pin external fixation, hybrid thin-wire external fixation, and plate fixation. In recent years, intramedullary nailing technique is widely used for  proximal and distal tibial metaphyseal fracture (Meena et al., 2015). Out of these techniques, most widely used are minimally invasive Plating and Intramedullary Nailing technique.

Intramedullary Nailing provides better functional outcomes and provides required mechanical stability and better fracture alignment. Intramedullary tibia nails can be implant via different approached including reamed & unreamed, compression and non compressive and locking options include static, dynamic and dynamic compression (Duygun, 2018).

In this post-marketing clinical follow-up study, the safety and effectiveness of intramedullary nailing system, which is intended for Tibia bone related fracture would be studied. 
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