Degenerative Joint Disease
Conditions
Keywords
Degenerative joint disease, Total Hip Arthroplasty
Brief summary
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
Detailed description
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem. Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.
Interventions
DEVICETotal Hip Arthroplasty
Total hip arthroplasty with the R3 Acetabular Hip system.
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following characteristics for inclusion in the study. * Patient is 18-75 years old and he/she is skeletally mature * Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis) * Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk * The patient is willing to comply the follow-up schedule
Exclusion criteria
Subjects with any of the following characteristics must be excluded from the participation in the study. * Patient has active infection or sepsis (treated or untreated) * Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse. * Patients with acute hip trauma (femoral neck fracture)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship | up to 10 years post-operatively | Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit. |
| Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome). |
| Radiographic Findings: Atrophy | 1 years, 3 years, 5 years, 7 years, 10 years | Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones |
| Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome). |
| Radiographic Findings: Osteolysis | 1 years, 3 years, 5 years, 7 years, 10 years | Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following: * Osteolysis \> 2mm in any Cup Zones * Osteolysis \> 2mm in any Stem Zones |
| Radiographic Findings: Radiolucent Lines (RLL) | 1 years, 3 years, 5 years, 7 years, 10 years | Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following: * RLL \> 2mm in any Cup Zones * RLL \> 2mm in any Stem Zones |
| Radiographic Findings: Hypertrophy | 1 years, 3 years, 5 years, 7 years, 10 years | Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following: * Hypertrophy in any Cup Zones * Hypertrophy in any Stem Zones |
Countries
Belgium, Denmark, Finland, Germany, Netherlands, Spain, United Kingdom
Participant flow
Pre-assignment details
The data from one (1) enrolled hip (1 participant) were entirely removed due to questions regarding the validity of the participant's consent.
Participants by arm
| Arm | Count |
|---|---|
| R3™ Acetabular System Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem) | 478 |
| R3™ Acetabular System Total hip replacement with the R3™ Acetabular System (cemented or cementless hip stem) | 501 |
| Total | 979 |
Baseline characteristics
| Characteristic | R3™ Acetabular System |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 9.02 |
| Body Mass Index (BMI) | 28.0 kg/m^2 STANDARD_DEVIATION 5.11 |
| Region of Enrollment Belgium | 97 hips |
| Region of Enrollment Denmark | 104 hips |
| Region of Enrollment Finland | 142 hips |
| Region of Enrollment Germany | 38 hips |
| Region of Enrollment Netherlands | 38 hips |
| Region of Enrollment Spain | 33 hips |
| Region of Enrollment United Kingdom | 49 hips |
| Sex: Female, Male Female | 284 hips |
| Sex: Female, Male Male | 217 hips |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 37 / 478 |
| other Total, other adverse events | 329 / 478 |
| serious Total, serious adverse events | 371 / 478 |
Outcome results
Primary
Implant Survivorship
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
Time frame: up to 10 years post-operatively
Population: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R3™ Acetabular System | Implant Survivorship | 0.89 percentage of hips |
Secondary
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Population: Full Analysis Set (FAS) population included participants enrolled and implanted with the study device with data available from at least one post-operative assessment for the time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | Pre-operative | 37.8 score on a scale | Standard Deviation 16.16 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 3 Months | 83.2 score on a scale | Standard Deviation 12.39 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 1 Year | 88.1 score on a scale | Standard Deviation 12.48 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 3 Years | 87.9 score on a scale | Standard Deviation 12.22 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 5 Years | 88.0 score on a scale | Standard Deviation 13.76 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 7 Years | 87.5 score on a scale | Standard Deviation 12.43 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | 10 Years | 89.3 score on a scale | Standard Deviation 10.69 |
Secondary
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Population: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 1 Year | 92.2 score on a scale | Standard Deviation 11.67 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 3 Years | 92.2 score on a scale | Standard Deviation 10.91 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 5 Years | 93.1 score on a scale | Standard Deviation 10.93 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 7 Years | 92.3 score on a scale | Standard Deviation 10.9 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 10 Years | 92.5 score on a scale | Standard Deviation 10.71 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | Pre-operative | 51.5 score on a scale | Standard Deviation 14.25 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | 3 Months | 85.5 score on a scale | Standard Deviation 13.78 |
Secondary
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Population: Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | Pre-operative | 3.4 score on a scale | Standard Deviation 1.35 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 3 Months | 5.2 score on a scale | Standard Deviation 1.56 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 1 Year | 6.1 score on a scale | Standard Deviation 1.58 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 3 Years | 6.1 score on a scale | Standard Deviation 1.66 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 5 Years | 6.1 score on a scale | Standard Deviation 1.66 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 7 Years | 5.7 score on a scale | Standard Deviation 1.61 |
| R3™ Acetabular System | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | 10 Years | 5.6 score on a scale | Standard Deviation 1.71 |
Secondary
Radiographic Findings: Atrophy
Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following: * Atrophy in any Cup Zones * Atrophy in any Stem Zones
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Population: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Cup Zones | No | 431 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Stem Zones | No | 428 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Stem Zones | Yes | 3 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 1 Year: Atrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Cup Zones | No | 413 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Stem Zones | No | 411 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Stem Zones | Yes | 2 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 3 Years: Atrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Cup Zones | No | 357 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Stem Zones | No | 357 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Stem Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 5 Years: Atrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Cup Zones | No | 334 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Stem Zones | No | 332 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Stem Zones | Yes | 2 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 7 Years: Atrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Cup Zones | No | 293 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Cup Zones | N/A | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Stem Zones | No | 290 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Stem Zones | Yes | 3 hips |
| R3™ Acetabular System | Radiographic Findings: Atrophy | 10 Years: Atrophy in any Stem Zones | N/A | 1 hips |
Secondary
Radiographic Findings: Hypertrophy
Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following: * Hypertrophy in any Cup Zones * Hypertrophy in any Stem Zones
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Population: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Cup Zones | No | 427 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Cup Zones | Yes | 4 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Stem Zones | No | 399 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Stem Zones | No | 325 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Stem Zones | Yes | 9 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Cup Zones | No | 293 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Stem Zones | No | 281 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Stem Zones | Yes | 32 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 1 Year: Hypertrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Cup Zones | No | 412 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Cup Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Stem Zones | No | 350 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Stem Zones | Yes | 63 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 3 Years: Hypertrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Cup Zones | No | 357 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Stem Zones | No | 347 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Stem Zones | Yes | 10 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 5 Years: Hypertrophy in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Cup Zones | No | 334 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 7 Years: Hypertrophy in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Cup Zones | N/A | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Stem Zones | Yes | 11 hips |
| R3™ Acetabular System | Radiographic Findings: Hypertrophy | 10 Years: Hypertrophy in any Stem Zones | N/A | 2 hips |
Secondary
Radiographic Findings: Osteolysis
Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following: * Osteolysis \> 2mm in any Cup Zones * Osteolysis \> 2mm in any Stem Zones
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Population: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Stem Zones | No | 401 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Stem Zones | Yes | 5 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Cup Zones | Yes | 6 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Cup Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Cup Zones | N/A | 12 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Cup Zones | No | 403 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Cup Zones | Yes | 4 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Cup Zones | N/A | 24 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 1 Year: Osteolysis > 2mm in any Stem Zones | N/A | 25 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Cup Zones | No | 383 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Cup Zones | Yes | 6 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Cup Zones | N/A | 24 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Stem Zones | No | 380 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Stem Zones | Yes | 7 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 3 Years: Osteolysis > 2mm in any Stem Zones | N/A | 26 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Cup Zones | No | 326 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Cup Zones | N/A | 25 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Stem Zones | No | 326 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Stem Zones | Yes | 4 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 5 Years: Osteolysis > 2mm in any Stem Zones | N/A | 27 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Cup Zones | No | 322 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Cup Zones | Yes | 2 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Cup Zones | N/A | 10 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Stem Zones | No | 317 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Stem Zones | Yes | 7 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 7 Years: Osteolysis > 2mm in any Stem Zones | N/A | 10 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Cup Zones | No | 281 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Stem Zones | No | 273 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Stem Zones | Yes | 9 hips |
| R3™ Acetabular System | Radiographic Findings: Osteolysis | 10 Years: Osteolysis > 2mm in any Stem Zones | N/A | 12 hips |
Secondary
Radiographic Findings: Radiolucent Lines (RLL)
Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following: * RLL \> 2mm in any Cup Zones * RLL \> 2mm in any Stem Zones
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Population: Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Cup Zones | No | 431 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Stem Zones | No | 430 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Stem Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 1 Year: RLL > 2mm in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Cup Zones | No | 413 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Cup Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Stem Zones | No | 413 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Stem Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 3 Years: RLL > 2mm in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Cup Zones | No | 356 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Cup Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Stem Zones | No | 357 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Stem Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 5 Years: RLL > 2mm in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Cup Zones | No | 333 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Cup Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Cup Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Stem Zones | No | 334 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Stem Zones | Yes | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 7 Years: RLL > 2mm in any Stem Zones | N/A | 0 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Cup Zones | No | 292 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Cup Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Cup Zones | N/A | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Stem Zones | No | 292 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Stem Zones | Yes | 1 hips |
| R3™ Acetabular System | Radiographic Findings: Radiolucent Lines (RLL) | 10 Years: RLL > 2mm in any Stem Zones | N/A | 1 hips |