Knee Replacement
Gone are the days when patients followed blindly, rarely asking questions or learning more about their conditions and the procedures recommended to them. With healthcare costs as well as innovations on the rise, today patients are more educated than ever concerning their health, often performing their own research before having any medical procedures done. Since having surgery can be an intimidating venture, learning all you can about your knee replacement procedure is a wise decision, especially with recent developments in innovations as well as FDA regulations. After all, it's always best to know beforehand what you're getting into, in order to maximize options and optimize recovery time.
History of knee replacement surgery
Joint replacement procedures date back as far as 1821, when a Westminster Hospital doctor performed the first arthroplasty. The first knee replacement surgeries, however, were performed in 1891 by German surgeon T. Gluck. Dr. Gluck experimented with many different types of materials to perform his arthroplasties, even harvesting pig bladders to cushion the knee joint, thereby relieving pain and restoring range of motion. He is also believed to have been the first surgeon to perform a true knee replacement, using an ivory ball and socket affixed by nickel-plated screws and was stabilized with metal or plaster. Little advancement was made in these types of knee replacements until the 1950s. Even though his materials and procedure were updated several times throughout this period, the metal and plastic components proved inflexible and prone to complications. However, in 1974 researchers at Massachusetts General Hospital developed a rounded plastic component that more closely resembled the actual structure of the knee, allowing for total joint replacement, now known as 'total condylar knee.'
Types of implants
There are several types of materials that can be used in knee replacement surgeries. These often differ depending on the manufacturing companies that produce these implants, although most companies manufacture more than one type. With the many varying types of implants on the market today, it can be difficult to decide what material would work best. Doctors and patients must make this decision together, which is why patients need to educate themselves on the varying types of materials used. The best implant typically depends on what type of surgery is being done and what the patient's normal activities of daily living will be following surgery, with a particular implant's track record good evidence to use in any decision. Some of the materials used are tantalum, cobalt-chromium, and its alloys. Titanium tends to be the preferred material because it does not react with the human body. Cobalt-chromium is also very bio-compatible. It is also very durable; however, this material can release tiny metal ions due to friction. Though usually harmless, if you have sensitivity to nickel or other metals, a reaction from these tiny metals can develop. Another material used is tantalum, which also has excellent bio-compatible properties. Tantalum is the key component used in a new bone/metal structure called 'trabecular metal,' which is produced with small mesh holes that actually foster bone regrowth. This can help to create a better bridge between the metal and the bone.
Rules relating to compliance
The Food and Drug Administration (FDA) regulates a wide range of medical devices from tongue depressors to artificial hearts. In order to reach U.S. consumers, medical devices must meet FDA standards. Federal regulation of implant devices is stricter than ever, due largely to recent defective hip replacement joints that have caused patients the necessity of undergoing further surgeries. The legal issues that ensued from these defective materials have caused the FDA to crack down on manufacturers of implants. The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers who produce, re-label, repackage, and/or import these surgical devices that are sold in the United States. All domestic and foreign manufacturers who wish to distribute their products in the U.S. must register their establishments with the FDA, and they must re-register every year. Medical device manufacturers must also list their products, and the FDA stipulates that all medical devices are proved to be safe and effective before put on the U.S. market. Devices must pass the FDA's pre-market approval test, and manufacturers must follow current good manufacturing processes. One example of this would be ensuring that work environments are sterile in order to prevent contamination. From there, the devices are labeled according to materials associated with the device and instructions, as well as other possible uses.
History of knee replacement surgery
Joint replacement procedures date back as far as 1821, when a Westminster Hospital doctor performed the first arthroplasty. The first knee replacement surgeries, however, were performed in 1891 by German surgeon T. Gluck. Dr. Gluck experimented with many different types of materials to perform his arthroplasties, even harvesting pig bladders to cushion the knee joint, thereby relieving pain and restoring range of motion. He is also believed to have been the first surgeon to perform a true knee replacement, using an ivory ball and socket affixed by nickel-plated screws and was stabilized with metal or plaster. Little advancement was made in these types of knee replacements until the 1950s. Even though his materials and procedure were updated several times throughout this period, the metal and plastic components proved inflexible and prone to complications. However, in 1974 researchers at Massachusetts General Hospital developed a rounded plastic component that more closely resembled the actual structure of the knee, allowing for total joint replacement, now known as 'total condylar knee.'
Types of implants
There are several types of materials that can be used in knee replacement surgeries. These often differ depending on the manufacturing companies that produce these implants, although most companies manufacture more than one type. With the many varying types of implants on the market today, it can be difficult to decide what material would work best. Doctors and patients must make this decision together, which is why patients need to educate themselves on the varying types of materials used. The best implant typically depends on what type of surgery is being done and what the patient's normal activities of daily living will be following surgery, with a particular implant's track record good evidence to use in any decision. Some of the materials used are tantalum, cobalt-chromium, and its alloys. Titanium tends to be the preferred material because it does not react with the human body. Cobalt-chromium is also very bio-compatible. It is also very durable; however, this material can release tiny metal ions due to friction. Though usually harmless, if you have sensitivity to nickel or other metals, a reaction from these tiny metals can develop. Another material used is tantalum, which also has excellent bio-compatible properties. Tantalum is the key component used in a new bone/metal structure called 'trabecular metal,' which is produced with small mesh holes that actually foster bone regrowth. This can help to create a better bridge between the metal and the bone.
Rules relating to compliance
The Food and Drug Administration (FDA) regulates a wide range of medical devices from tongue depressors to artificial hearts. In order to reach U.S. consumers, medical devices must meet FDA standards. Federal regulation of implant devices is stricter than ever, due largely to recent defective hip replacement joints that have caused patients the necessity of undergoing further surgeries. The legal issues that ensued from these defective materials have caused the FDA to crack down on manufacturers of implants. The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers who produce, re-label, repackage, and/or import these surgical devices that are sold in the United States. All domestic and foreign manufacturers who wish to distribute their products in the U.S. must register their establishments with the FDA, and they must re-register every year. Medical device manufacturers must also list their products, and the FDA stipulates that all medical devices are proved to be safe and effective before put on the U.S. market. Devices must pass the FDA's pre-market approval test, and manufacturers must follow current good manufacturing processes. One example of this would be ensuring that work environments are sterile in order to prevent contamination. From there, the devices are labeled according to materials associated with the device and instructions, as well as other possible uses.