N/A
N=478
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
Degenerative Joint Disease
Bottom Line
View on ClinicalTrials.gov: NCT04399928 ↗Enrolled (actual)
478
Serious AEs
77.6%
Results posted
Apr 2025
Primary outcome: Primary: Implant Survivorship — 0.89 percentage of hips
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Total Hip Arthroplasty (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew Orthopaedics AG
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survivorship |
0.89 | — |
| SECONDARY Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) |
37.8; 83.2; 88.1; 87.9; 88.0; 87.5 | — |
| SECONDARY Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) |
51.5; 85.5; 92.2; 92.2; 93.1; 92.3 | — |
| SECONDARY Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating |
3.4; 5.2; 6.1; 6.1; 6.1; 5.7 | — |
| SECONDARY Radiographic Findings: Atrophy |
431; 0; 0; 428; 3; 0 | — |
| SECONDARY Radiographic Findings: Hypertrophy |
427; 4; 0; 399; 32; 0 | — |
| SECONDARY Radiographic Findings: Osteolysis |
403; 4; 24; 401; 5; 25 | — |
| SECONDARY Radiographic Findings: Radiolucent Lines (RLL) |
431; 0; 0; 430; 1; 0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04399928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.