ABC/Trident® Ceramic Post Approval Study
Post-Approval Study of the ABC and Trident® Systems
1 other identifier
interventional
413
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2003
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedFebruary 3, 2017
December 1, 2016
7.6 years
August 5, 2009
June 7, 2013
December 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Component Revision and Complications
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 Outcomes (3)
Harris Hip Score
3-5 and 10 Years
Radiographic Evaluation
3-5 and 10 years
Hip Follow-Up Questionnaire
6-10 years
Study Arms (3)
Trident®System
EXPERIMENTALTrident® Ceramic Insert/Trident® AD HA Acetabular Shell
ABC System
EXPERIMENTALAlumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Control
ACTIVE COMPARATOROmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Interventions
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Orthopaedic Surgery Associates
Boca Raton, Florida, 33435, United States
Emory Univeristy
Atlanta, Georgia, 30329, United States
Indiana University
Indianapolis, Indiana, 46202, United States
New England Baptist Hospital
Boston, Massachusetts, 02120, United States
Toledo Joint Replacement and Orthopedic Center
Toledo, Ohio, 43623, United States
Greater Pittsburgh Orthopaedics Assoc.
Moon Township, Pennsylvania, 15108, United States
Results Point of Contact
- Title
- Director of Clinical Research
- Organization
- Stryker Orthopaedics
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 17, 2009
Study Start
March 1, 2003
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 3, 2017
Results First Posted
August 15, 2014
Record last verified: 2016-12