Multi-Center Comparative Trial of the ASRâ„¢-XL Acetabular Cup System vs. the Pinnacleâ„¢ Metal- on- Metal Total Hip System
Summary
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Description
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Osteoporosis
Intervention
ASR™-XL Modular Acetabular Cup System, Pinnacle™ acetabular shell
Location
Desert Orthopaedics
Rancho Mirage
California
United States
92270
Status
Completed
Source
DePuy Orthopaedics
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00561600
- Information obtained from ClinicalTrials.gov on June 28, 2012
Medical and Biotech [MESH] Definitions
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
Hip Dislocation, Congenital
Congenital dislocation of the hip generally includes subluxation of the femoral head, acetabular dysplasia, and complete dislocation of the femoral head from the true acetabulum. This condition occurs in approximately 1 in 1000 live births and is more common in females than in males.
Cementation
The joining of objects by means of a cement (e.g., in fracture fixation, such as in hip arthroplasty for joining of the acetabular component to the femoral component). In dentistry, it is used for the process of attaching parts of a tooth or restorative material to a natural tooth or for the attaching of orthodontic bands to teeth by means of an adhesive.
Click Chemistry
Organic chemistry methodology that mimics the modular nature of various biosynthetic processes. It uses highly reliable and selective reactions designed to "click" i.e., rapidly join small modular units together in high yield, without offensive byproducts. In combination with COMBINATORIAL CHEMISTRY TECHNIQUES, it is used for the synthesis of new compounds and combinatorial libraries.
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PubMed Articles
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