Clinical trial NCT00960206: ABC/Trident® Ceramic Post Approval Study
Official title: Post-Approval Study of the ABC and Trident® Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 413
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Component Revision and Complications
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 3-5 and 10 Years
measure: Radiographic Evaluation
timeFrame: 3-5 and 10 years
measure: Hip Follow-Up Questionnaire
timeFrame: 6-10 years
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Orthopaedic Surgery Associates
state: Florida
city: Atlanta
country: United States
facility: Emory Univeristy
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Toledo
country: United States
facility: Toledo Joint Replacement and Orthopedic Center
state: Ohio
city: Moon Township
country: United States
facility: Greater Pittsburgh Orthopaedics Assoc.
state: Pennsylvania
Study officials:
affiliation: Indiana University School of Medicine
name: William Capello, MD
role: STUDY_CHAIR
affiliation: New England Baptist Hospital
name: Benjamin Bierbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Greater Pittsburgh Orthopaedic Associates
name: James D'Antonio, MD
role: STUDY_CHAIR
affiliation: Emory Orthopaedics Center
name: James Roberson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toledo Joint Replacement and Orthopedic Center
name: Scott Siverhus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Surgery Associates
name: Robert Zann, MD
role: PRINCIPAL_INVESTIGATOR
References: