ABC/Trident® Ceramic Post Approval Study

December 8, 2016 updated by: Stryker Orthopaedics

Post-Approval Study of the ABC and Trident® Systems

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
413

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33435
        • Orthopaedic Surgery Associates
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Univeristy
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • New England Baptist Hospital
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Toledo Joint Replacement and Orthopedic Center
    • Pennsylvania
      • Moon Township, Pennsylvania, United States, 15108
        • Greater Pittsburgh Orthopaedics Assoc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trident®System
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Experimental: ABC System
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
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
Active Comparator: Control
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Component Revision and Complications
Time Frame: 10 years
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: 3-5 and 10 Years

Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.

90 - 100 = excellent

80 - 89 = good

70 - 79 = fair

0 - 69 = poor
3-5 and 10 Years
Radiographic Evaluation
Time Frame: 3-5 and 10 years
Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.
3-5 and 10 years
Hip Follow-Up Questionnaire
Time Frame: 6-10 years
A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below).
6-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Orthopaedics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: William Capello, MD, Indiana University School of Medicine
  • Principal Investigator: Benjamin Bierbaum, MD, New England Baptist Hospital
  • Study Chair: James D'Antonio, MD, Greater Pittsburgh Orthopaedic Associates
  • Principal Investigator: James Roberson, MD, Emory Orthopaedics Center
  • Principal Investigator: Scott Siverhus, MD, Toledo Joint Replacement and Orthopedic Center
  • Principal Investigator: Robert Zann, MD, Orthopaedic Surgery Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 33/45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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