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CTRI Number  CTRI/2024/05/067023 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
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   Hip Replacement System PMCF Study 
Scientific Title of Study   A retrospective, multicentre, observational, real-world post-market clinical follow-up study to evaluate the safety & effectiveness of Libertasâ„¢ Hip Replacement System is intended for use in total hip arthroplasty and hemi-hip arthroplasty 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHPL/ Libertasâ„¢ Hip Replacement V1.0.0 dated 6 Dec 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirankumar Shetty 
Designation  Senior Manager- Product Performance and 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 and 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 and 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  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailendra T Patil  Aditi Hospital  Department of Orthopedic,First Floor, Alhad - 185 / R, Purushottam Kheraj Rd, opp. Kalidas Road, Mulund West-400080, Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA 
9320620978

shailendra_patil@yahoo.com 
Dr Ashwani Maichand  CK Birla Hospital  Department of Orthopaedic, Ground Floor, 57/41, West Punjabi Bagh-110026, Punjabi Bagh, New Delhi, Delhi, , India.
New Delhi
DELHI 
9811129607

a_maichand@yahoo.com 
Dr Hiren K Shah  Star Hospital  Department of Orthopedic,Ground Floor, Lal Bahadur Shastri Rd, near Indica Laboratories, Vadilal Park, Bapunagar, Ahmedabad-380024, Gujarat, India
Ahmadabad
GUJARAT 
9825359331

dr.hiren.msortho@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
OM Institutional Ethics Committee  Submittted/Under Review 
OM Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients who were treated with the Libertas Hip
Replacement System and will have completed a minimum
of 2-year follow-up 
 
ExclusionCriteria 
Details  As this 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 
1. Mobility
2. Post-operative complications
3. Revision
 
1. Time frame: 24 months post-discharge
2. Time Frame: through 24
months
3. Time frame: through 5 year, through 10
year
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Occurrence of surgical site complication
2. Swelling
3. Visual analog scale
4. Adverse events 
1. Time frame: through 1 year, through 2 year, Through 5 year, through 10 year
2. Time frame: through 1 year
3. Time frame: through 1
year, through 2 year, Through 5 year, through 10 year
4. Time frame: through 1 year, through 2 year, Through 5 year, through 10 year 
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
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)   20/05/2024 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Libertasâ„¢ Hip Replacement System PMCF Study: A retrospective, multicentre, observational, real-world post-market clinical follow-up study to evaluate the safety & effectiveness of Libertasâ„¢ Hip Replacement System isintended for use in total hip arthroplasty and hemi-hip arthroplasty

Protocol ID, Version & Date: MHPL/ Libertasâ„¢ Hip Replacement System PMCF Study Protocol_Version: 1.0.0_06-Dec-2023

Objective:: To evaluate the safety and performance of the Libertasâ„¢ Hip Replacement System intended for use in total hip arthroplasty and hemi-hip arthroplasty.

Study Design: A retrospective, multicenter, observational, real-world, postmarketclinical follow-up study.

Study population: All consecutive patients who underwent surgical intervention using Libertasâ„¢ Hip Replacement System and have a minimum of 2-year of follow-up completed.

Number of patients: 159 patients

Indication: The Libertas â„¢ Hip Replacement System is intended for use in total hip arthroplasty and hemi-hip arthroplasty. Total hip arthroplasty isintended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components. Hemi-hip arthroplasty is performed in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to fix and support the femoral stem.

Total hip replacement is indicated for the following conditions:
1. Non-inflammatory degenerative joint diseases, including osteoarthritis, post-traumatic arthritis, and vascular necrosis 
2. Rheumatoid arthritis 
3. Acute traumatic fracture of the femoral head or neck 
4. Certain cases of Ankylosis ï‚§ Dislocation of the hip 
5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur 

Hemi-hip arthroplasty is indicated in the following conditions: 
1. Acute traumatic fracture of the femoral head or neck that cannot be appropriately treated with internal fixation 
2. Fracture dislocation of the hip that cannot be appropriately treated with internal fixation. 
3. Avascular necrosis of femoral head 
4.Certain high sub-capital and femoral neck fractures in the elderly. 
5. Degenerative arthritis involves only the femoral head, in which the acetabulum does not require replacement. 

 
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