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Hip Replacement System PMCF Study

A retrospective, multicentre, observational, real-world post-market clinical follow-up study to evaluate the safety & effectiveness of Libertas™ Hip Replacement System is intended for use in total hip arthroplasty and hemi-hip arthroplasty - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/05/067023
Enrollment
159
Registered
2024-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M169- Osteoarthritis of hip, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who were treated with the Libertas Hip Replacement System and will have completed a minimum of 2-year follow-up

Exclusion criteria

Exclusion criteria: As this is a retrospective review of data, there are no formal exclusion criteria for the study

Design outcomes

Primary

MeasureTime frame
1. Mobility 2. Post-operative complications 3. Revision Timepoint: 1. Time frame: 24 months post-discharge 2. Time Frame: through 24 months 3. Time frame: through 5 year, through 10 year—

Secondary

MeasureTime frame
1. Occurrence of surgical site complication 2. Swelling 3. Visual analog scale 4. Adverse eventsTimepoint: 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—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026