Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe (R3 EU PAS)
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|ClinicalTrials.gov Identifier: NCT03566082|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
|Condition or disease|
|Degenerative Joint Disease of Hip|
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 Type :||Observational|
|Actual Enrollment :||137 participants|
|Official Title:||Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe|
|Actual Study Start Date :||February 10, 2017|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||November 15, 2021|
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.
- Implant survivor rate [ Time Frame: 10 Years ]Did hip survive with no revision through 10 years
- Modified Harris Hip Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 Years ]All AEs will be collected and reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566082
|HUS Peijaksen sairaala, Ortopedia ja traumatologia|
|Helsinki, Finland, 00029|
|TYKS Turku University Hospital|
|Turku, Finland, 20880|
|La Paz Hospital|
|Madrid, Spain, 28046|
|The Royal Orthopaedic Hospital, NHS Foundation Trust|
|Birmingham, United Kingdom, B 31 2AP|