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NCT03056534 · ClinicalTrials.gov registry record
R3 Delta Ceramic Acetabular System PAS U.S.
A clinical trial of Degenerative Joint Disease, sponsored by Smith & Nephew.
- Completed
- Registry status
- 189
- Enrollment target
- 8
- Study locations
NCT03056534: Completed study of Degenerative Joint Disease, sponsored by Smith & Nephew.
NCT03056534 is a study of Degenerative Joint Disease that has completed, run by Smith & Nephew. The registered enrollment target is 189 participants, below the 395-participant average among 4 other Degenerative Joint Disease trials with a reported enrollment target (52% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056534, a study of Degenerative Joint Disease, has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- 189 participants
- Enrollment target
- 8
- Study locations
Study Summary
R3 Delta Post-Approval Study U.S.
Primary Outcome
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetab
Conditions Studied
Interventions
- DEVICE R3 Biolox Delta Ceramic Acetabular System
Study Locations (8)
Maryland
- Luminis Health - Annapolis
- Rubin Institute for Advanced Orthopedics, Sinai Hospital - Baltimore
Texas
- St. David's Center for Hip and Knee Replacement - Austin
- INOV8 Healthcare - Houston
Florida
- Foundation for Orthopaedic Research and Education - Tampa
Georgia
- Emory University - Tucker
Nevada
- Reno Orthopaedic Clinic Foundation - Reno
Pennsylvania
- University of Pennsylvania, Department of Orthopaedic Surgery - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2018-02-07 |
| Est. Completion | 2023-05-31 |
What the finished NCT03056534 record still lists
NCT03056534 is an observational study that tracks outcomes without assigning an intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 395-participant average among 4 other Degenerative Joint Disease trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Degenerative Joint Disease appearing as the primary indexed condition, and to 1 intervention - of which R3 Biolox Delta Ceramic Acetabular System is the first listed.
NCT03056534 lists 8 locations in 6 states (Maryland, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT03056534 about?
NCT03056534 is a clinical study titled "R3 Delta Ceramic Acetabular System PAS U.S.". R3 Delta Post-Approval Study U.S.
What is the current status of trial NCT03056534?
This trial is currently completed. The enrollment target is 189 participants. The study started on 2018-02-07. Estimated completion is 2023-05-31.
What conditions does trial NCT03056534 study?
This clinical trial studies the following conditions: Degenerative Joint Disease.
What interventions are being tested in trial NCT03056534?
The interventions under investigation include: R3 Biolox Delta Ceramic Acetabular System (DEVICE).
Who is sponsoring clinical trial NCT03056534?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03056534 being conducted?
This trial has 8 study locations across Florida, Georgia, Maryland, Nevada, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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