Hip Replacement System PMCF Study
Not Applicable
- Conditions
- Health Condition 1: M169- Osteoarthritis of hip, unspecified
- Registration Number
- CTRI/2024/05/067023
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
As this is a retrospective review of data, there are no formal exclusion criteria for the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mobility <br/ ><br>2. Post-operative complications <br/ ><br>3. Revision <br/ ><br>Timepoint: 1. Time frame: 24 months post-discharge <br/ ><br>2. Time Frame: through 24 <br/ ><br>months <br/ ><br>3. Time frame: through 5 year, through 10 <br/ ><br>year <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Occurrence of surgical site complication <br/ ><br>2. Swelling <br/ ><br>3. Visual analog scale <br/ ><br>4. Adverse eventsTimepoint: 1. Time frame: through 1 year, through 2 year, Through 5 year, through 10 year <br/ ><br>2. Time frame: through 1 year <br/ ><br>3. Time frame: through 1 <br/ ><br>year, through 2 year, Through 5 year, through 10 year <br/ ><br>4. Time frame: through 1 year, through 2 year, Through 5 year, through 10 year