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ABC/Trident® Ceramic Post Approval Study

NCT00960206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2017-02-03

Study results available
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Summary

The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

Conditions

  • Arthroplasty, Replacement, Hip

Interventions

DEVICE

Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell

Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell

DEVICE

OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

DEVICE

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Sponsors & Collaborators

  • Stryker Orthopaedics

    lead INDUSTRY

Principal Investigators

  • William Capello, MD · Indiana University School of Medicine

  • Benjamin Bierbaum, MD · New England Baptist Hospital

  • James D'Antonio, MD · Greater Pittsburgh Orthopaedic Associates

  • James Roberson, MD · Emory Orthopaedics Center

  • Scott Siverhus, MD · Toledo Joint Replacement and Orthopedic Center

  • Robert Zann, MD · Orthopaedic Surgery Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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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 NCT00960206 on ClinicalTrials.gov