ABC/Trident® Ceramic Post Approval Study

Not Applicable

Completed

Conditions: Arthroplasty, Replacement, Hip

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

Registration Number: NCT00960206

Lead Sponsor: Stryker Orthopaedics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 413

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 Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell	OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Trident®System	Trident® Ceramic Insert/Trident® AD HA Acetabular Shell	Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
ABC System	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

Primary Outcome Measures

Name	Time	Method
Component Revision and Complications	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	3-5 and 10 Years	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
Hip Follow-Up Questionnaire	6-10 years	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).
Radiographic Evaluation	3-5 and 10 years	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.

Trial Locations

Locations (6): Orthopaedic Surgery Associates
🇺🇸
Boca Raton, Florida, United States
Emory Univeristy
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Atlanta, Georgia, United States
Greater Pittsburgh Orthopaedics Assoc.
🇺🇸
Moon Township, Pennsylvania, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Toledo Joint Replacement and Orthopedic Center
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Toledo, Ohio, United States
New England Baptist Hospital
🇺🇸
Boston, Massachusetts, United States