Pinnacle RSA Study

NCT04070989 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-19

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04070989 on ClinicalTrials.gov