1. Ceramax Ceramic Total Hip Replacement
DePuy Orthopaedics, Inc.
P070026
http://www.depuy.com/pinnacleclinical
Medical Problem:
The Ceramax™ Ceramic Hip is a complete hip joint replacement for patients whose natural hip joint can no longer be used due to pain or ineffectiveness from arthritis, injury, or dislocation.1 The hip system is for “rehabilitation of hips
damaged as a result of non-inflammatory degenerative joint diseases (NIDJD) [such as] osteoarthritis”.2
Osteoarthritis is a “condition in which the joints of the body are damaged, stop moving freely and become painful. This happens when the cartilage covering the ends of bones tears away, and the bone underneath thickens due to aging”.3
Design Criteria: (http://orthoinfo.aaos.org/topic.cfm?topic=A00355)
•
A total hip replacement is a common way to treat osteoarthritis
•
Hip replacement must have: the stem (fits into the femur), the ball (replaces the spherical head of the femur), and the cup (replaces the hip socket)
•
Specific design of replacement depends on age, weight, bone quality, activity level, and health
•
Ball portions must be smooth to allow easy rotation in the cup
•
Device should weigh between 14 and 18 ounces
•
Materials in a device must:
•
Be biocompatible
•
Be resistant to corrosion, degradation, and wear so as to retain their strength and shape for a long time
•
Have a high elastic modulus to withstand weight-bearing loads
•
Examples: titanium- or cobalt/chromium-based alloys
•
Be able to elastically deform to ensure some flexibility with movements
•
Hip implants should last at least 15 years. It is expected that more surgery will eventually be required for the patient
•
Cemented total hip replacement is more commonly recommended for older patients
•
Cementless total hip replacements should have a surface coating around much of the implant so that the new bone grows into the surface of the implant and stabilizes the implant
•
Cementless total hip replacement is most often recommended for younger, more active patients and patients with good bone quality where bone ingrowth into the device can be achieved
Description of Product
•
Ceramic on Ceramic
Mainly for patients getting surgery for rehabilitation of hips after non-inflammatory degenerative joint disease (NIDJD) or from osteoarthritis, avascular necrosis, or post-traumautic arthritis
•
Uses new type of ceramic material specialized for hip replacement surgery
•
Uses BIOLOX delta Ceramic Femoral Heads which is a zirconia-toughened, platelet-reinforcing alumina ceramic (see pic on website)
•
Better material strength and toughness
•
74% alumina, 25% zirconia
•
Cementless total hip replacement for skeletally mature people
Developers also designed the Cup System with various technologies to better suit individuals and be better equipped for integration with the human body
•
Advanced Modularity: Variable Interface Prosthesis (VIP) taper technology (see link on website for more info)
•
Supports PE liners and hard bearing inserts
•
Allows macro and micro stability since it can function as a support and lock system
•
Fixation Technologies: (see links on website for photos)
•
Porocoat Porous Coating
•
Supports more biological fixation to bone
•
Made of titanium sintered metal beads--lets bone attach into the porous coating
•
Gription Porous Coating
•
Ultra-porous, super-textured surface
•
Immediately grips and clings to deficient bony anatomy
•
Pinnacle DuoFix HA Shells
•
Plasma sprayed Hydroxyapatite (35 micron thick layer)
•
The HA doesn’t inhibit the pores of the coating which could make it difficult for the in-growth of tissue
Advanced Materials:
•
“The materials used in the PINNACLE Acetabular Cup System offer mechanical integrity, wear resistance and oxidative stability. DePuy's advanced modularity and range of solutions allow surgeons to match the right
components to each patient’s needs. This is a consideration more important than ever, considering today's patients are demanding far more from implants than patients from previous generations.”
•
•
•