Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System

Study Overview
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Brief Summary
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The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.

Official Title
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A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.

Conditions
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Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head, Osteoarthritis (OA), Hip Dislocation, Hip Fractures

Intervention / Treatment
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* Device: OR3O™ - Dual Mobility System
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a suitable candidate for implanting the OR3O™ Dual Mobility System or single-bearing design Total Hip System in primary 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 is receiving total hip replacement for the first time on the affected hip. 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; 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 Ethical Committee (EC) 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. Subjects with preoperative HHS ≤ 79 (fair or worse category). Exclusion Criteria: 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 weak constitution or failing to endure the surgery due to other diseases of the body. Subject has bodily disease(s) that may interfere with THA survival or outcome. Subject has life expectancy of less than 2 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 a mental or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse. 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. Subjects that are expected with poor compliance. Subjects with complications of other diseases are limited to participate in the research, not able to comply with the follow-up or have impact on scientific integrity. Subjects with preoperative HHS ≥ 80 (good to excellent category). Subject has other diseases or conditions that investigator considers not appropriate to participate in the study.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm (dual mobility)<br>OR3O™ Dual Mobility in subjects who undergo Primary THA. | Device: OR3O™ - Dual Mobility System<br>* OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).<br>|
| Active Comparator: Controlled Arm (conventional)<br>A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. | Device: Conventional<br>* A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium (Ox) femoral head.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) at 1 year | Proportion of excellent (≥ 90) or good (80-89) HHS scores at 12 month postoperative. 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship After Surgery | Survivorship of the OR3O™ Dual Mobility System. Survivorship of controlled system is defined as no revision due to any reason. | 6 weeks, 3 months, 6 months, 1 year and 2 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). HHS scores for each subject will further be categorized as follows: Excellent (90-100); Good (80-89); Fair (70-79); Poor (60-69) and; Very poor (<60). Shift tables from the preoperative visit to all postoperative visits using these classifications will be generated. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score | The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome. | Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 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). | Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Implant Position/Orientation: Depth | Implant position/orientation depth determined by Acetabular Cup Position. Depth will be graded in accordance with the following definitions: 0. Neutral: The acetabular cup is seated against the ilio-ischial line. 1. Medial: The acetabular cup is medial to the ilios-ischial line. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Implant Position/Orientation: Height | Implant position/orientation height determined Acetabular Cup Position. Height will be graded in accordance with the following definitions: 0. Neutral: The inferior aspect of the acetabular cup is at the level of the teardrop. 1. Superior: The inferior aspect of the acetabular cup is superior to the level of the teardrop. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Implant Subsidence/Migration | Acetabular Cup Migration will be graded for the shell and liner assembly, in accordance with the following definitions: 0. Absent: No evidence of acetabular cup migration ≥ 3 mm. 1. Present: Presence of acetabular cup migration ≥ 3 mm. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Heterotopic Ossification | Heterotopic Ossification will be classified based on the following: Grade 0: None, no islands of bone Grade I: Islands of bone within the soft tissues about the hip Grade II: Bone spurs from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces Grade III: Bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm Grade IV: Apparent bone ankylosis of the hip An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Radiolucencies | Radiolucency - Acetabular Cup is defined as the presence of a linear gap or halo along the acetabular bone-implant interface and will be classified as: 0: None: no evidence of a linear (double-line) periacetabular line or halo >1 mm along the acetabular bone-implant interface. 1: Present: Presence of a linear (double-line) periacetabular line or halo >1 mm along the acetabular bone-implant interface. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Osteolysis | Osteolysis is classified as: 0. None: No evidence of a ballooning / scalloping, progressive,periacetabular, bony destructive lesion with a maximum dimension > 5mm. 1. Present: Presence of a ballooning / scalloping, progressive,periacetabular, bony destructive lesion with a maximum dimension > 5mm. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Implant Loosening | Acetabular Cup Loosening will be graded in accordance with the following definitions: 0. Absent: No evidence of specific imaging features of loosening at the acetabular bone-implant interface including significant radiolucency or change in position of the acetabular cup indicating a loss of fixation. 1. Present: Presence of apparent imaging features of loosening at the acetabular bone-implant interface including significant radiolucency or change in position of the acetabular cup indicating a loss of fixation. An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Stress Shielding | Image review by investigator to identify presence of medial stress shielding (yes/no). An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 
| Radiographic Assessment - Periprosthetic Fractures | Image review by investigator to identify presence of periprosthetic fractures (yes/no). An AP and a lateral view radiograph are required to adequately assess the status of the study device. Radiographs will be performed with the subject in a supine position. | 6 weeks, 3 months, 6 months, 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty (THA)