ABC/Trident® Ceramic Post Approval Study

Completed · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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.

Key facts

Study ID

NCT00960206

Run by

Stryker Orthopaedics

People needed

413

Starts

2003-03-01

Expected to finish

2010-10-01

Last updated by the study team

2017-02-03

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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