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

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  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.