| 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
|
|
|
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
|
|
|
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 arthroplastyProtocol 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.
|