N/A
N=135
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
Degenerative Joint Disease of Hip
Bottom Line
View on ClinicalTrials.gov: NCT03566082 ↗Enrolled (actual)
135
Serious AEs
61.5%
Results posted
May 2024
Primary outcome: Primary: Implant Survivorship — 133; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew Orthopaedics AG
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survivorship |
133; 2 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
47.9; 92; 92.5; 92; 92.6 | — |
| SECONDARY Number of Participants With Radiographic Success |
111; 4; 101; 5; 90; 5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03566082). 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.