Trials / Completed
CompletedNCT03056534
R3 Delta Ceramic Acetabular System PAS U.S.
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 189 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
Summary
R3 Delta Post-Approval Study U.S.
Detailed description
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | R3 Biolox Delta Ceramic Acetabular System | All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU). |
Timeline
- Start date
- 2018-02-07
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2017-02-17
- Last updated
- 2025-04-13
- Results posted
- 2025-04-13
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03056534. Inclusion in this directory is not an endorsement.