Status:
COMPLETED
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Degenerative Joint Disease
Eligibility:
All Genders
18-75 years
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...
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 cemente...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 18 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT04399928
Start Date
May 18 2009
End Date
April 1 2022
Last Update
April 11 2025
Active Locations (8)
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1
AZ Nikolaas
Sint-Niklaas, Moerlandstraat 1, Belgium, 9100
2
Hvidovre University Hospital
Hvidovre, Denmark, 2650
3
Helsinki University Hospital
Helsinki, Finland, FI-00029
4
TYKS Turku University Hospital
Turku, Finland, 20880