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Status:

COMPLETED

ABC/Trident® Ceramic Post Approval Study

Lead Sponsor:

Stryker Orthopaedics

Conditions:

Arthroplasty, Replacement, Hip

Eligibility:

All Genders

21-75 years

Phase:

NA

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 sh...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2010

    Estimated Enrollment :

    413 Patients enrolled

    Trial Details

    Trial ID

    NCT00960206

    Start Date

    March 1 2003

    End Date

    October 1 2010

    Last Update

    February 3 2017

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Orthopaedic Surgery Associates

    Boca Raton, Florida, United States, 33435

    2

    Emory Univeristy

    Atlanta, Georgia, United States, 30329

    3

    Indiana University

    Indianapolis, Indiana, United States, 46202

    4

    New England Baptist Hospital

    Boston, Massachusetts, United States, 02120