Trident® X3 Polyethylene Insert Study

Summary

The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

DEVICE

Trident® X3 Polyethylene Insert

Trident® X3 Polyethylene Insert

Sponsors & Collaborators

• Stryker Orthopaedics

  lead INDUSTRY

Principal Investigators

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

• Benjamin Bierbaum, MD · New England Baptist Hospital Deptartment of Orthopaedics

• Peter Bonutti, MD · Bonutti Clinic

• William Capello, MD · Indiana University School of Medicine

• Michael Taunton, MD · Mayo Clinic Department of Orthopaedic Surgery

• Robert Johnson, MD · University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation

• J. Wesley Mesko, MD · Michigan Orthopaedic Center

• James R Roberson, MD · Emory Orthopaedics

• John Wright, MD · New West Orthopaedics

• Daniel Ward, MD · New England Baptist Hospital Department of Orthopaedics

• Russell Meldrum, MD · Indiana University School of Medicine

• J. Andrew Parr, MD · Indiana University School of Medicine

• Steven Incavo, MD · University of Vermont

• Greg Erens, MD · Emory Orthopaedics

• Robert Trousdale, MD · Mayo Clinic Department of Orthopaedic Surgery

• Alren Hanssen, MD · Mayo Clinic Department of Orthopaedic Surgery

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-05-31

Primary Completion

2012-07-31

Completion

2016-12-31

Countries

• United States

Study Locations