N/A
N=189
R3 Delta Ceramic Acetabular System PAS U.S.
Degenerative Joint Disease
Bottom Line
View on ClinicalTrials.gov: NCT03056534 ↗Enrolled (actual)
189
Serious AEs
37.0%
Results posted
Apr 2025
Primary outcome: Primary: Overall Study Success at 3 Years Postoperative — 100; 13 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- R3 Biolox Delta Ceramic Acetabular System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Study Success at 3 Years Postoperative |
100; 13 | — |
| PRIMARY Component Revisions at 3 Years Postoperative |
135; 1 | — |
| PRIMARY Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points |
114; 10 | — |
| PRIMARY Overall Radiographic Success at 3 Years Postoperative |
106; 2 | — |
| PRIMARY Number of Participants With Absence of Radiolucency at 3 Years Postoperative |
119; 0 | — |
| PRIMARY Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative |
119; 0 | — |
| PRIMARY Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative |
106; 2 | — |
| SECONDARY Modified Hip Harris Score (mHHS) |
47.60; 89.60; 91.10; 93.00; 93.50 | — |
| SECONDARY Radiographic Findings: Number of Participants With Absence of Radiolucency |
155; 1; 142; 0; 135; 0 | — |
| SECONDARY Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration |
156; 0; 142; 0; 135; 0 | — |
| SECONDARY Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes |
137; 4; 127; 3; 122; 3 | — |
| SECONDARY Implant Survivorship Kaplan-Meier Estimate |
99.4 | — |
Summary
R3 Delta Post-Approval Study U.S.
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 (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic 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
- Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
- Patient has consented to participating in the study by signing the IRB/EC approved informed consent form
Exclusion Criteria
- Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
- Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
- Patients with active joint infections or chronic systemic infection
- Obese patients where obesity is defined as BMI ≥ 40
- Skeletal immaturity
- Known allergy to implant materials
Data sourced from ClinicalTrials.gov (NCT03056534). 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.