AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.

500 patients was the enrollment goal with 2 subgroups.

• Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements;
• Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.

Inclusion criteria

• Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically

• Primary osteoarthritis
• Post-Traumatic arthritis
• Inflammatory joint disease (e.g. Rheumatoid arthritis)
• Femoral neck fracture
• Femoral head necrosis
• Sequelae from previous hip surgery, osteotomies, etc.
• Congenital hip dysplasia

Additional inclusion criteria include:

• Male or female
• 18 years of age or older
• Subjects willing to return for follow-up evaluations
• Subjects who read, understand study information and give written consent (specific local regulatory requirements)

Exclusion criteria

• Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®

RELOAD:

Absolute contraindications include:

• Infection
• Sepsis
• Severe muscular, neurological or vascular deficiencies of the extremity involved
• Bone destruction or poor bone quality

Additional contraindications include:

• Subjects unable to co-operate with and complete the study
• Dementia and inability to understand and follow instructions
• Neurological conditions affecting movement
• Patient over 18 under law supervision