Pinnacle RSA Study

Sponsor
DePuy Orthopaedics
Study ID
NCT04070989
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THA — DEVICE
    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem

Study Details

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.

Key Dates

Start date
Dec 3, 2019
Status verified
Dec 2025
Primary completion
Jun 12, 2023
Completion
Jun 16, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Posterior Approach
    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the posterior approach
  • Experimental: Lateral Approach
    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the lateral approach
  • Experimental: Anterior Approach
    Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem implanted via the anterior approach

Primary Outcome Measure

Mean Superior Cup Migration (Subsidence) at 6 Week and 2 Years [ Time Frame: At 6 week and 2 years ]

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