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CTRI Number  CTRI/2024/04/065554 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective, Post Marketing Clinical Follow-up Study 
Study Design  Single Arm Study 
Public Title of Study   Intramedullary Nails 
Scientific Title of Study   A retrospective, multi-center, observational, real-world post-market clinical follow-up study to evaluate the safety & performance of Intramedullary nails used in the fixation of long bone fractures,including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHPL/ Intramedullary Nails PMCF Studyv1.0.0 11 Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirankumar Shetty 
Designation  Senior Manager- Product Performance & Engineering Department 
Affiliation  Meril Life Sciences Pvt. Ltd 
Address  Meril Life Sciences Pvt Ltd. Buidling number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India

Valsad
GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kirankumar Shetty 
Designation  Senior Manager- Product Performance & Engineering Department 
Affiliation  Meril Life Sciences Pvt. Ltd 
Address  Meril Life Sciences Pvt Ltd. Buidling number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India


GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Details of Contact Person
Public Query  
Name  Dr Kirankumar Shetty 
Designation  Senior Manager- Product Performance & Engineering Department 
Affiliation  Meril Life Sciences Pvt. Ltd 
Address  Meril Life Sciences Pvt Ltd. Buidling number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India


GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Source of Monetary or Material Support  
Meril Healthcare Pvt. Ltd. H1-H3, Meril Park Survey No. 1575 and 1088, Muktanand Marg, Chala Vapi- 396191 Gujarat, India 
 
Primary Sponsor  
Name  Meril Life Sciences Pvt Ltd 
Address  Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India  
Type of Sponsor  Other [Medical Device Company ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSunil Dash  AMRI Hospitals  Department of Orthopedic, Plot No. 1, Near Jayadev Vatika Park, Khandagiri, Bhubaneswar, Shankarpur, Odisha 751019
Khordha
ORISSA 		 9891973900

drsunil_dash@yahoo.com 
DrTirthankar Bhattacharya  Apex Institute of Medical Sciences  Department of Orthopedic, 1219, Sammilani Park Rd, near Big Bazar, Hiland Park, Survey Park, Santoshpur, Kolkata, West Bengal 700075
Kolkata
WEST BENGAL 		 9831092126

bukchu@gmail.com 
Dr Vishnu Vajpai  Arihant Hospital  18, Main, Haridwar Rd, Shastri Nagar, Ajabpur Kalan, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 7619820242

vishnu1010vajpai@gmail.com 
DrYogesh Chaudhari  Ashoka Medicover Hospital  Department of Orthopedic, Shree Sant Savata Mali Marg, Parab Nagar, Nashik, Maharashtra 422009
Nashik
MAHARASHTRA 		 9011086920

dryogeshchaudhari@gmail.com 
Dr Akash Singhal  Kailash Hospital  Main Haridwar Road, Chowk, Jogiwala, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 9464120869

akash15636@gmail.com 
Dr Sandeep Dathik  Kanishk Hospital  I.S.B.T Road, Main, Haridwar Bypass Rd, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 9873795219

2951georgian@gmail.com 
Dr Syed Imran  Manipal Hospital  Ground Floor, Millers Rd, opp. Annes College, Vasanth Nagar, Bengaluru, Karnataka
Bangalore
KARNATAKA 		 9620202828

ortho.drimran@gmail.com 
DrBaban Ojha  PGIMER & Capital Hospital  Department of Orthopedic,Unit 6, Ganga Nagar, Bhubaneswar, Odisha 751025
Khordha
ORISSA 		 9891973900

doc.baban022@gmail.com 
Dr Haresh Bhalodiya  Saviour Hospital  2HW6+38V, Sardar Patel Stadium Rd, near Bharat Petrol Pump, Chaitanya Nagar, Navrangpura, Ahmedabad-380014, Gujarat, India.
Ahmadabad
GUJARAT 		 9327999818

hbhalodiya26@gmail.com 
Dr Faiz Akbar Siddiqui  Swami Rama Himalayan University  Ground Floor, Swami Ram Nagar, beside Jolly Grant, near Himalayan Hospital Road, Airport, Joly Grant, Doiwala, Sangatiya Walakhur, Uttarakhand 248016
Dehradun
UTTARANCHAL 		 9871424061

drfaizsiddiqui@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M979||Periprosthetic fracture around unspecified internal prosthetic joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who have been treated with Intramedullary Nails and have completed a minimum of 02 year follow up 
 
ExclusionCriteria 
Details  Asthis is a retrospective review of data, there are no formal exclusion criteria for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of re-operation
 		 Time Frame: Through 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean Operation Time in minutes
2.Post-operative hospital stay
3.Any Device Malfunction or Device Failure
4.Post-operative mobility
5.Adverse event 		 1.Time Frame: Intraoperative
2.Time Frame: After operation
3.Intra and Post-operative through 2 - year
4.Time Frame: 2-year
5.Time Frame: 2-year 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
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   N/A 
Date of First Enrollment (India)   30/04/2024 
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)
Modification(s)  		 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   Study Title: Intramedullary Nails PMCF Study: A retrospective, multi-center, observational, real-world postmarket clinical follow-up study to evaluate the safety & performance of Intramedullary nails used in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal

Study Design: A retrospective, multi-center, observational, real-world postMarket clinical follow-up study.

Objective: To evaluate the safety and performance of Intramedullary Nails used in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal.

Follow-ups: As this is a retrospective study, the patient’s records will be reviewed for only observations and the data will be collected over 2 years.

Indication: Intramedullary Nails indicated in the fixation of Long Bone Fractures, including Diaphyseal Fractures in the Humerus, Tibia, Femur, and Shaft Fractures 5 cm below the Surgical Neck and 5 cm proximal to the distal end of the Medullary Canal.
 
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