Avascular Necrosis of Femoral Head, Degenerative Hip Joint Disease, Femoral Neck Fractures, Hip Dislocation, Hip Fractures, Osteoarthritis (OA), Rheumatoid Arthritis (RA)
Conditions
Keywords
Total Hip Arthroplasty (THA)
Brief summary
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.
Interventions
DEVICEOR3O™ - Dual Mobility System
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).
DEVICEConventional
A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium (Ox) femoral head.
Sponsors
Smith & Nephew Medical (Shanghai) Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months | 12 months | Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes). 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | Preoperative, 6 weeks, 6 months, and 12 months | The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores range from 0 (worst) to 100 (best). |
| EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | Preoperative, 6 weeks, 6 months, and 12 months | The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score is on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome). |
| EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | Preoperative, 6 weeks, 6 months, and 12 months | 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) to create a combined Health Score. The combined Health Score is on a scale of 0 to 1 with a higher score indicating a better outcome. |
| Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | Preoperative, 6 weeks, 6 months, and 12 months | 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 Total Hip Arthroplasty (THA). HOOS JR. accesses pain and joint awareness during the activities of daily living. The scores range from 0 to 100 with 0 indicating total hip disability (i.e., the worst outcome) and 100 indicating perfect hip health (i.e., the best outcome). |
| Radiographic Assessment - Implant Position/Orientation | 6 months and 12 months | Implant position/orientation determined by acetabular cup position from radiographs performed with the participant in a supine position. Participant implant position was categorized as one of the following: * Unchanged * Varus tilted * Valgus tilted * Subsidence |
| Radiographic Assessment - Implant Subsidence/Migration | 6 months and 12 months | Acetabular Cup Migration was determined based on cup fixation from radiographs with the subject in a supine position. Participant implant subsidence/migration was categorized as one of the following: * Unchanged * Migration cranial * Migration medial * Tilted |
| Survivorship of the OR3O™ Dual Mobility System | 6 weeks, 3 months, 6 months, and 12 months | Survivorship of the OR3O™ Dual Mobility System measured by Kaplan-Meier survival estimate. Survivorship was defined as number of hips with no revision due to any reason. |
| Radiographic Assessment - Radiolucencies | 6 months and 12 months | Radiolucencies in the Acetabular Cup are defined as the presence of a linear gap or halo along the acetabular bone-implant interface identified from radiographs performed with the subject in a supine position. The presence of radiolucent lines for participants in any cup zones were categorized as either 'Yes' or 'No'. |
| Radiographic Assessment - Osteolysis | 6 months and 12 months | Osteolysis was determined from radiographs performed with the subject in a supine position. The presence of osteolysis in any cup zones for the participant identified as 'Yes' or 'No'. Presence of osteolysis indicated a ballooning / scalloping, progressive, periacetabular, bony destructive lesion with a maximum dimension \> 5 millimeters (mm). |
| Radiographic Assessment - Implant Loosening | 6 months and 12 months | Implant loosening was determined from radiographs performed with the subject in a supine position. The presence of loosening indicated 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. Implant loosening based on stem fixation for cemented stems for the participant was categorized as one of the following: * Not applicable * No loosening * Possible loosening * Probable loosening * Definite loosening |
| Radiographic Assessment - Stress Shielding | 6 months and 12 months | Image review by investigator of radiographs performed with the subject in a supine position to identify presence of medial stress shielding. Stress shielding for the participant based on the presence (Yes/No) of the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones |
| Radiographic Assessment - Periprosthetic Fractures | 6 months and 12 months | 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 performed with the subject in a supine position. |
| Radiographic Assessment - Heterotopic Ossification | 6 months and 12 months | Heterotopic Ossification determined from radiographs performed with the subject in a supine position using Brooker Classification. Heterotopic ossification for the participant was classified as one of 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) |
Countries
China
Participant flow
Pre-assignment details
A total of 24 participants were consented. Two participants were excluded from the study prior to receiving study treatment due to screen failure and withdrawal by the participant.
Participants by arm
| Arm | Count |
|---|---|
| Study Arm (Dual Mobility) OR3O™ Dual Mobility in subjects who undergo Primary THA.
OR3O™ - Dual Mobility System: 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). | 11 |
| Controlled Arm (Conventional) A conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
Conventional: A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium (Ox) femoral head. | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Study terminated by sponsor | 11 | 10 |
Baseline characteristics
| Characteristic | Study Arm (Dual Mobility) | Controlled Arm (Conventional) | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 10.5 | 65.1 years STANDARD_DEVIATION 9.6 | 60.8 years STANDARD_DEVIATION 10.8 |
| Age, Customized Age Category < 60 years | 8 Participants | 2 Participants | 10 Participants |
| Age, Customized Age Category ≥ 60 years | 3 Participants | 9 Participants | 12 Participants |
| Body Mass Index (BMI) | 25.2 kg/m^2 STANDARD_DEVIATION 3.3 | 23.5 kg/m^2 STANDARD_DEVIATION 3.7 | 24.4 kg/m^2 STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized Race Chinese | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Race Han | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 1 / 11 |
| other Total, other adverse events | 3 / 11 | 4 / 11 |
| serious Total, serious adverse events | 3 / 11 | 3 / 11 |
Outcome results
Primary
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
Number of participants with an excellent (≥ 90) or good (80-89) Harris Hip Score at 12 months postoperative (No/Yes). 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).
Time frame: 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Arm (Dual Mobility) | Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months | No | 1 Participants |
| Study Arm (Dual Mobility) | Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months | Yes | 6 Participants |
| Controlled Arm (Conventional) | Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months | No | 4 Participants |
| Controlled Arm (Conventional) | Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months | Yes | 3 Participants |
Secondary
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health 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) to create a combined Health Score. The combined Health Score is on a scale of 0 to 1 with a higher score indicating a better outcome.
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | Preoperative | 0.36 score on a scale | Standard Deviation 0.3 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 6 weeks | 0.63 score on a scale | Standard Deviation 0.02 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 6 months | 0.74 score on a scale | Standard Deviation 0.11 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 12 months | 0.79 score on a scale | Standard Deviation 0.11 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 6 weeks | 0.69 score on a scale | — |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | Preoperative | 0.37 score on a scale | Standard Deviation 0.25 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 6 months | 0.71 score on a scale | Standard Deviation 0.14 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Health Score | 12 months | 0.73 score on a scale | Standard Deviation 0.19 |
Secondary
EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score
The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The EQ VAS score is on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome).
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | Preoperative | 51.82 score on a scale | Standard Deviation 27.14 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 6 weeks | 72.5 score on a scale | Standard Deviation 3.54 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 6 months | 78 score on a scale | Standard Deviation 11.35 |
| Study Arm (Dual Mobility) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 12 months | 81.43 score on a scale | Standard Deviation 9 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 12 months | 79.29 score on a scale | Standard Deviation 8.86 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | Preoperative | 55.91 score on a scale | Standard Deviation 17.44 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 6 months | 76.67 score on a scale | Standard Deviation 9.68 |
| Controlled Arm (Conventional) | EuroQol (European Quality of Life) Five-dimensional Five-level (EQ-5D-5L) Score: Visal Analogue Scale (VAS) Score | 6 weeks | 80 score on a scale | — |
Secondary
Harris Hip Score (HHS)
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores range from 0 (worst) to 100 (best).
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Harris Hip Score (HHS) | Preoperative | 34.09 score on a scale | Standard Deviation 22.42 |
| Study Arm (Dual Mobility) | Harris Hip Score (HHS) | 12 months | 81.86 score on a scale | Standard Deviation 4.74 |
| Study Arm (Dual Mobility) | Harris Hip Score (HHS) | 6 months | 73.1 score on a scale | Standard Deviation 7.45 |
| Study Arm (Dual Mobility) | Harris Hip Score (HHS) | 6 weeks | 71 score on a scale | — |
| Controlled Arm (Conventional) | Harris Hip Score (HHS) | 6 weeks | 51 score on a scale | — |
| Controlled Arm (Conventional) | Harris Hip Score (HHS) | Preoperative | 31.55 score on a scale | Standard Deviation 19.44 |
| Controlled Arm (Conventional) | Harris Hip Score (HHS) | 6 months | 72.33 score on a scale | Standard Deviation 6.78 |
| Controlled Arm (Conventional) | Harris Hip Score (HHS) | 12 months | 75.71 score on a scale | Standard Deviation 8.65 |
Secondary
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 Total Hip Arthroplasty (THA). HOOS JR. accesses pain and joint awareness during the activities of daily living. The scores range from 0 to 100 with 0 indicating total hip disability (i.e., the worst outcome) and 100 indicating perfect hip health (i.e., the best outcome).
Time frame: Preoperative, 6 weeks, 6 months, and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | Preoperative | 54.29 score on a scale | Standard Deviation 23.57 |
| Study Arm (Dual Mobility) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 6 weeks | 64.68 score on a scale | Standard Deviation 8.13 |
| Study Arm (Dual Mobility) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 6 months | 80.42 score on a scale | Standard Deviation 8.88 |
| Study Arm (Dual Mobility) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 12 months | 83.83 score on a scale | Standard Deviation 10.14 |
| Controlled Arm (Conventional) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 12 months | 74.91 score on a scale | Standard Deviation 15.12 |
| Controlled Arm (Conventional) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | Preoperative | 46.69 score on a scale | Standard Deviation 18.37 |
| Controlled Arm (Conventional) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 6 months | 79.25 score on a scale | Standard Deviation 15.29 |
| Controlled Arm (Conventional) | Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR.) | 6 weeks | 67.52 score on a scale | — |
Secondary
Radiographic Assessment - Heterotopic Ossification
Heterotopic Ossification determined from radiographs performed with the subject in a supine position using Brooker Classification. Heterotopic ossification for the participant was classified as one of 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)
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade 0 | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade I | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade II | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade III | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade IV | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade 0 | 7 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade I | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade II | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade III | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade IV | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade II | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade 0 | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade 0 | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade I | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade IV | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade II | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade I | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade III | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 12 months | Grade III | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Heterotopic Ossification | 6 months | Grade IV | 0 Participants |
Secondary
Radiographic Assessment - Implant Loosening
Implant loosening was determined from radiographs performed with the subject in a supine position. The presence of loosening indicated 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. Implant loosening based on stem fixation for cemented stems for the participant was categorized as one of the following: * Not applicable * No loosening * Possible loosening * Probable loosening * Definite loosening
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 6 months | Possible loosening | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 6 months | Not applicable | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 6 months | No loosening | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 6 months | Probable loosening | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 6 months | Definite loosening | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 12 months | Not applicable | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 12 months | No loosening | 7 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 12 months | Possible loosening | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 12 months | Probable loosening | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Loosening | 12 months | Definite loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 12 months | Possible loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 6 months | Definite loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 12 months | Not applicable | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 6 months | Not applicable | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 12 months | Definite loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 6 months | No loosening | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 6 months | Possible loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 12 months | No loosening | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 6 months | Probable loosening | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Loosening | 12 months | Probable loosening | 0 Participants |
Secondary
Radiographic Assessment - Implant Position/Orientation
Implant position/orientation determined by acetabular cup position from radiographs performed with the participant in a supine position. Participant implant position was categorized as one of the following: * Unchanged * Varus tilted * Valgus tilted * Subsidence
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 6 months | Varus tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 6 months | Unchanged | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 6 months | Valgus tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 6 months | Subsidence | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 12 months | Unchanged | 7 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 12 months | Varus tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 12 months | Valgus tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Position/Orientation | 12 months | Subsidence | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 12 months | Subsidence | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 6 months | Varus tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 12 months | Unchanged | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 6 months | Unchanged | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 12 months | Valgus tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 6 months | Valgus tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 12 months | Varus tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Position/Orientation | 6 months | Subsidence | 0 Participants |
Secondary
Radiographic Assessment - Implant Subsidence/Migration
Acetabular Cup Migration was determined based on cup fixation from radiographs with the subject in a supine position. Participant implant subsidence/migration was categorized as one of the following: * Unchanged * Migration cranial * Migration medial * Tilted
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Unchanged | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Migration cranial | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Migation medial | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Tilted | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Unchanged | 7 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Migration cranial | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Migation medial | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Migation medial | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Tilted | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Unchanged | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Migration cranial | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Migration cranial | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 12 months | Unchanged | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Implant Subsidence/Migration | 6 months | Migation medial | 0 Participants |
Secondary
Radiographic Assessment - Osteolysis
Osteolysis was determined from radiographs performed with the subject in a supine position. The presence of osteolysis in any cup zones for the participant identified as 'Yes' or 'No'. Presence of osteolysis indicated a ballooning / scalloping, progressive, periacetabular, bony destructive lesion with a maximum dimension \> 5 millimeters (mm).
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Osteolysis | 6 months | No | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Osteolysis | 12 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Osteolysis | 6 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Osteolysis | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Osteolysis | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Osteolysis | 6 months | No | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Osteolysis | 6 months | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Osteolysis | 12 months | Yes | 0 Participants |
Secondary
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 performed with the subject in a supine position.
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Periprosthetic Fractures | 6 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Periprosthetic Fractures | 6 months | No | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Periprosthetic Fractures | 12 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Periprosthetic Fractures | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Periprosthetic Fractures | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Periprosthetic Fractures | 6 months | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Periprosthetic Fractures | 12 months | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Periprosthetic Fractures | 6 months | No | 3 Participants |
Secondary
Radiographic Assessment - Radiolucencies
Radiolucencies in the Acetabular Cup are defined as the presence of a linear gap or halo along the acetabular bone-implant interface identified from radiographs performed with the subject in a supine position. The presence of radiolucent lines for participants in any cup zones were categorized as either 'Yes' or 'No'.
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Radiolucencies | 6 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Radiolucencies | 6 months | No | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Radiolucencies | 12 months | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Radiolucencies | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Radiolucencies | 12 months | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Radiolucencies | 6 months | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Radiolucencies | 12 months | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Radiolucencies | 6 months | No | 3 Participants |
Secondary
Radiographic Assessment - Stress Shielding
Image review by investigator of radiographs performed with the subject in a supine position to identify presence of medial stress shielding. Stress shielding for the participant based on the presence (Yes/No) of the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones
Time frame: 6 months and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study. Radiographs only collected at 6 months \& 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Stem Zones | No | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Cup Zones | No | 4 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Cup Zones | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Cup Zones | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Stem Zones | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Stem Zones | Yes | 0 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Stem Zones | No | 7 Participants |
| Study Arm (Dual Mobility) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Cup Zones | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Stem Zones | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Cup Zones | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Cup Zones | No | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Stem Zones | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 6 months: Atrophy in any Stem Zones | No | 3 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Cup Zones | No | 7 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Stem Zones | Yes | 0 Participants |
| Controlled Arm (Conventional) | Radiographic Assessment - Stress Shielding | 12 months: Atrophy in any Cup Zones | Yes | 0 Participants |
Secondary
Survivorship of the OR3O™ Dual Mobility System
Survivorship of the OR3O™ Dual Mobility System measured by Kaplan-Meier survival estimate. Survivorship was defined as number of hips with no revision due to any reason.
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Population: Safety Analysis (SAF) population included participants assigned to a study arm with data collected for the outcome and time frame specified. Data was only collected up to the 12 month time point due to premature termination of the study.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Study Arm (Dual Mobility) | Survivorship of the OR3O™ Dual Mobility System | 6 weeks | 11 hips |
| Study Arm (Dual Mobility) | Survivorship of the OR3O™ Dual Mobility System | 3 months | 10 hips |
| Study Arm (Dual Mobility) | Survivorship of the OR3O™ Dual Mobility System | 6 months | 10 hips |
| Study Arm (Dual Mobility) | Survivorship of the OR3O™ Dual Mobility System | 12 months | 5 hips |
| Controlled Arm (Conventional) | Survivorship of the OR3O™ Dual Mobility System | 12 months | 5 hips |
| Controlled Arm (Conventional) | Survivorship of the OR3O™ Dual Mobility System | 6 weeks | 11 hips |
| Controlled Arm (Conventional) | Survivorship of the OR3O™ Dual Mobility System | 6 months | 9 hips |
| Controlled Arm (Conventional) | Survivorship of the OR3O™ Dual Mobility System | 3 months | 10 hips |