R3 EU PAS: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Post Approval Study The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure. |
Outcome Measures
Primary Outcome Measures
- Implant survivor rate [10 Years]
Did hip survive with no revision through 10 years
Secondary Outcome Measures
- Modified Harris Hip Score [10 Years]
Effectiveness assessed by comparison of changes in parameters from baseline through 10 year post. 2 subscales (8 items), Scores summed and normalized to 100, Excellent: 90 - 100 points Good: 80 - 89 points Fair: 70 - 79 points Poor: < 70 points
- Radiographic outcomes [10 Years]
radiographic success 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°)
- Adverse Events [10 Years]
All AEs will be collected and reported
Eligibility Criteria
Criteria
Inclusion Criteria:
Patient is 18-75 years old and he/she is skeletally mature
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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)
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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
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The patient is willing to comply the follow-up schedule
Exclusion Criteria:
Patient has active infection or sepsis (treated or untreated)
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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,
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Patients with acute hip trauma (femoral neck fracture)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Nikolaas | Sint-Niklaas | Belgium | ||
| 2 | HUS Peijaksen sairaala, Ortopedia ja traumatologia | Helsinki | Finland | 00029 | |
| 3 | TYKS Turku University Hospital | Turku | Finland | 20880 | |
| 4 | La Paz Hospital | Madrid | Spain | 28046 | |
| 5 | The Royal Orthopaedic Hospital, NHS Foundation Trust | Birmingham | United Kingdom | B 31 2AP |
Sponsors and Collaborators
- Smith & Nephew Orthopaedics AG
- eResearchTechnology, Inc
- M Squared Associates,Inc.
- ExecuPharm PAREXEL
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R11019