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A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing

2014-07-24 14:13:51 | BioPortfolio

Summary

The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Osteoarthritis

Intervention

Pinnacle™ Acetabular System, Pinnacle™ Acetabular System

Location

Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen
Germany

Status

Terminated

Source

DePuy International

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:13:51-0400

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PubMed Articles [16531 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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.

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.

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.

A group of enzymatic disorders affecting the nervous system and to a variable degree the skeletal system, lymphoreticular system, and other organs. The conditions are marked by an abnormal accumulation of catabolic material within lysosomes.

The system of glands that release their secretions (hormones) directly into the circulatory system. In addition to the ENDOCRINE GLANDS, included are the CHROMAFFIN SYSTEM and the NEUROSECRETORY SYSTEMS.

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