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
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.
Inclusion Criteria:
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:
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:
Exclusion Criteria:
All subjects:
Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
Subject has dysplasia of hip joint with CROWE Grade III, IV.
Subject has bodily disease(s) that may interfere with THA survival or outcome.
Subject has life expectancy of less than 10 years.
Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
Subject has an active infection - systemic or at the site of intended surgery.
Subject has a Body Mass Index > 40.0 kg/m².
Subject has a known allergy to any component of the devices used in the study.
Subject is pregnant or breast feeding.
Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
Revision Subjects: