Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-04 @ 8:04 AM
Study NCT ID:
NCT03056534
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
R3 Delta Ceramic Acetabular System PAS U.S.
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R3-PAS
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: