ABC/Trident® Ceramic Post Approval Study

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: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell; Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell; Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

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: Interventional
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	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	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	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

• Sponsor: Stryker Orthopaedics
• Investigators: 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

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 14, 2009
• First Posted (Estimate): August 17, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 33/45