Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures
The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.
∙ All subjects:
• Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System in primary or revision total hip replacement in the Investigator's judgement.
• Subject is skeletally mature in the Investigator's judgement.
• Subject is 18 - 80 years old (inclusive).
• Subject has any of the following conditions:
‣ Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis (RA);
⁃ Fracture or avascular necrosis of the femoral head;
⁃ Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
⁃ All forms of osteoarthritis (OA);
⁃ Patients with hips at risk of dislocation;
⁃ Femoral neck fracture or proximal hip joint fracture.
• Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form before any study procedures are performed, including pre-operative data review and/or collection of data on electronic Case Report Forms (eCRFs).
• Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
• Subject has all required study pre-operative and operative data available in their medical record for collection if consent is given after their THA surgery.
∙ Revision Subjects:
• Subject has a REDAPT™ Modular Shell implanted which does not require revision or will receive a REDAPT™ Modular Shell during revision THA.
• Subject has a S+N compatible stem which does not require revision or will receive a S+N compatible stem during revision THA.