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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
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
Component Revision and Complications
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.
Time frame: 10 years
Harris Hip Score
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
Time frame: 3-5 and 10 Years
Radiographic Evaluation
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.
Time frame: 3-5 and 10 years
Hip Follow-Up Questionnaire
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).
Time frame: 6-10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Toledo Joint Replacement and Orthopedic Center
Toledo, Ohio, United States
Greater Pittsburgh Orthopaedics Assoc.
Moon Township, Pennsylvania, United States