ABC/Trident® Ceramic Post Approval Study

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell; Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell; Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960206

33/45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 413 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 3 patient groups

Trident®System

Experimental group

Description:

Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

Treatment:

Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell

ABC System

Experimental group

Description:

Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell

Treatment:

Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell

Control

Active Comparator group

Description:

OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Treatment:

Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell