Degenerative Joint Disease of Hip
Conditions
Brief summary
The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.
Detailed description
This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study (A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease). The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.
Interventions
None listed
Sponsors
eResearchTechnology, Inc
M Squared Associates, Inc.
ExecuPharm PAREXEL
Iqvia Pty Ltd
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
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/ developmental dysplasia of the hip) 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
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 | 10 Years | Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive'). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Harris Hip Score (mHHS) | Pre-operative, 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. |
| Number of Participants With Radiographic Success | 3-years, 5-years, 7-years 10-years | Count of participants with radiographic success, where success is defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and * No acetabular cup inclination changes greater than 4 degrees (4°) Participants who did not meet criteria specified above were considered radiographic failures |
Countries
Belgium, Finland, Spain, United Kingdom
Participant flow
Recruitment details
Participants previously recruited & enrolled in the post-market approval (PMA) were considered enrolled in this post-approval study (PAS). Additional consent was not required (reviewed and approved by study sites' ethic committees) because the participants had existing consent from the PMA agreeing to be followed to the 10-year postoperative interval necessary for this PAS.
Participants by arm
| Arm | Count |
|---|---|
| Post Approval Study Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. | 135 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Failures (revision required) | 2 |
| Overall Study | Lost to Follow-up | 8 |
Baseline characteristics
| Characteristic | Post Approval Study | — |
|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 9.12 | — |
| Body Mass Index (BMI) | 27.7 kg/m^2 STANDARD_DEVIATION 4.73 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 61 Participants | — |
| Region of Enrollment Finland | 32 Participants | — |
| Region of Enrollment Spain | 20 Participants | — |
| Region of Enrollment United Kingdom | 22 Participants | — |
| Sex: Female, Male Female | 89 Participants | — |
| Sex: Female, Male Male | 46 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 135 |
| other Total, other adverse events | 99 / 135 |
| serious Total, serious adverse events | 83 / 135 |
Outcome results
Primary
Implant Survivorship
Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').
Time frame: 10 Years
Population: Participants with any data available at the time frame specified
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post Approval Study | Implant Survivorship | Hip Survived | 133 Participants |
| Post Approval Study | Implant Survivorship | Hip Did Not Survive (Revision Required) | 2 Participants |
Secondary
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-years, 5-years, 7-years, 10-years
Population: Participants with data available at time frames specifies
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Post Approval Study | Modified Harris Hip Score (mHHS) | Pre-operative | 47.9 score on a scale | Standard Deviation 12.02 |
| Post Approval Study | Modified Harris Hip Score (mHHS) | 3-year | 92 score on a scale | Standard Deviation 11.42 |
| Post Approval Study | Modified Harris Hip Score (mHHS) | 7-year | 92 score on a scale | Standard Deviation 10.83 |
| Post Approval Study | Modified Harris Hip Score (mHHS) | 10-year | 92.6 score on a scale | Standard Deviation 9.29 |
| Post Approval Study | Modified Harris Hip Score (mHHS) | 5-year | 92.5 score on a scale | Standard Deviation 10.61 |
Secondary
Number of Participants With Radiographic Success
Count of participants with radiographic success, where success is defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and * No acetabular cup inclination changes greater than 4 degrees (4°) Participants who did not meet criteria specified above were considered radiographic failures
Time frame: 3-years, 5-years, 7-years 10-years
Population: Number of participants with any data available for the time frame specified
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Post Approval Study | Number of Participants With Radiographic Success | 3-years | Success | 111 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 3-years | Failures | 4 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 5-years | Success | 101 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 5-years | Failures | 5 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 7-years | Success | 90 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 7-years | Failures | 5 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 10-years | Success | 97 Participants |
| Post Approval Study | Number of Participants With Radiographic Success | 10-years | Failures | 5 Participants |