ABC/Trident® Ceramic Post Approval Study

NCT ID: NCT00960206

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2010-10-31

Brief 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.

Detailed Description

The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trident®System

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Group Type: EXPERIMENTAL

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Intervention Type: DEVICE

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

ABC System

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Control

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Intervention Type: 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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
• The individual is between the ages of 21 and 75 years.
• The individual is not classified as morbidly obese.
• The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
• The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
• The individual does not have an active infection within the affected hip joint.
• The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.
• The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).
• The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.
• The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.
• The individual is skeletally mature.
• The individual is not pregnant.
• The individual is not a prisoner.
• The individual has no plans to relocate to another geographic area before the completion of the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Capello, MD

Role: STUDY_CHAIR

Indiana University School of Medicine

Benjamin Bierbaum, MD

Role: PRINCIPAL_INVESTIGATOR

New England Baptist Hospital

James D'Antonio, MD

Role: STUDY_CHAIR

Greater Pittsburgh Orthopaedic Associates

James Roberson, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Orthopaedics Center

Scott Siverhus, MD

Role: PRINCIPAL_INVESTIGATOR

Toledo Joint Replacement and Orthopedic Center

Robert Zann, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Associates

Locations

Orthopaedic Surgery Associates

Boca Raton, Florida, United States

Emory Univeristy

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

New England Baptist Hospital

Boston, Massachusetts, United States

Toledo Joint Replacement and Orthopedic Center

Toledo, Ohio, United States

Greater Pittsburgh Orthopaedics Assoc.

Moon Township, Pennsylvania, United States

Countries

United States

Other Identifiers

33/45

Identifier Type: -

Identifier Source: org_study_id