Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Degeneration of the Hip Joint, Revision of the Hip Joint

Intervention / Treatment
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* Device: Primary Total Hip Arthroplasty
* Device: Revision Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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: 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. Revision Subjects: Subject has a R3™ Acetabular Shell implanted which does not require revision or will receive a R3™ Acetabular Shell or 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. 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.: blood supply limitations; insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia; infections or other conditions which may lead to increased bone resorption. 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: Subject has inadequate proximal implant support with an increased risk of implant failure as proximal support is not achieved, poor bone quality exists, and smaller sized implants are utilized. Subject needs revision of a fractured ceramic head or liner. Subject was already enrolled into this study as primary THA case.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Total Hip Arthroplasty (THA)<br>OR3O Dual Mobility System used in primary THA | Device: Primary Total Hip Arthroplasty<br>* Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components<br>|
| Revision Total Hip Arthroplasty (THA)<br>OR3O Dual Mobility System used in revision THA | Device: Revision Total Hip Arthroplasty<br>* Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of Primary Total Hip Arthroplasty (THA) | Assess long-term survivorship (10 years after device implantation) of primary THA using the OR3O™ Dual Mobility System. Survivorship is defined as no revision of any of the THA components including OR3O™ Dual Mobility System (liner and insert), acetabular shell, femoral head and femoral stem. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of individual Total Hip Arthroplasty (THA) components (OR3O Dual Mobility, acetabular shell, femoral head) | Survivorship of the following specific components will be presented individually: OR3O™Dual Mobility System, Acetabular Shell, Femoral head. The endpoint of interest is time to occurrence of a revision of the specific component due to any reason. | up to 10 years | 
| Harris Hip Score (HHS) | The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best). | Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | 
| Five-level EuroQol five-dimensional (EQ-5D-5L) score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents. | Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years | 
| Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | The HOOS JR. is a short-form survey based on the Hip Disability and Osteoarthritis Outcome Score (HOOS) that specifically focuses on the outcome after THA. HOOS JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes - no, mild, moderate, severe, extreme) and each question gets a score from 0 to 4. An interval score from 0-100 (0 indicating total hip disability and 100 indicating perfect hip health) is calculated (15). | Pre-Op, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years | 
| Radiographic Assessment | Assessments to be made from radiographs will include implant position, implant fixation, heterotopic ossification, radiolucencies, osteolysis, atrophy and hypertrophy | 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | 
| Safety Assessment | All adverse events (AEs) occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events. | Surgery, Discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THA, OR3O, Dual Mobility, hip revision, hip replacement, hip joint, hip implant