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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 bearings that were ultimately approved via PreMarket Approval application in February of 2003. The study design was a prospective, multicenter, randomized, controlled clinical investigation. Six surgeons participated in both the ABC and Trident arms of the study and have the longest follow-up data. A subset of patients from the original study who consented to continue participation in the FDA Post Approval Study (PAS) continue to be followed to collect limited patient reported data regarding status of the hip. A total of 518 cases [310 ABC Study cases (214 ceramic / 96 control), 208 Trident cases] were active in the IDE study (IDE #G960148) as of March 12, 2003, when that study ended and the post-approval study began. There were 464 cases who originally agreed to participate in the PAS phase. Of the 464, there are 274 ABC (185 ABC ceramic cases, 89 control cases) and 190 Trident cases.
To continue to demonstrate safety the incidence of revisions and complications will be reported annually to 10 years. To demonstrate efficacy the overall functional performance, pain relief, range of motion, and radiographic evaluation will be measured at 7 and 10 years. Patient satisfaction as well as general health assessments will be completed at 7 and 10 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Arthroplasty, Replacement, Hip
Ceramic Post Approval
Orthopaedic Surgery Associates
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:19:57-0400
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In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on t...
Partial or total replacement of a joint.
Replacement of the hip joint.
Partial or total replacement of one or more FINGERS, or a FINGER JOINT.
Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Replacement of the ANKLE JOINT.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...