Pinnacle RSA Study
NCT04070989 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-12-19
Summary
The primary objective is to establish the mean superior cup migration of the Pinnacle Acetabular Shell using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. This will be summarized for each surgical approach separately, as well as combined.
Conditions
- Osteoarthritis
- Degenerative Arthritis
Interventions
- DEVICE
-
THA
Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
Sponsors & Collaborators
-
DePuy Orthopaedics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-03
- Primary Completion
- 2023-06-12
- Completion
- 2023-06-16
- FDA Device
- Yes
Countries
- Canada
Study Locations
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