Shoulder Replacement
Like knee or hip replacement procedures (arthroplasty), shoulder replacement surgery is used to treat medical conditions such as osteoarthritis and rheumatoid arthritis, which cause inflammation and pain. It can also be used to treat conditions such as rotator cuff tear and avascular necrosis, which is death of bone tissue due to lack of blood supply. According to the American Academy of Orthopedic Surgeons (AAOS), shoulder arthroplasty is not nearly as common as hip or knee replacement surgeries, with about 50,000 shoulder replacements being performed as opposed to nearly one million knee or hip replacement surgeries being done. Regardless, shoulder replacement surgeries are increasing in the U.S., as innovations in orthopedics and medical devices develop and as the U.S. population ages with baby boomers moving into middle and older age. In addition, because the shoulder has the greatest range of motion of any joint in the human body, more people are turning to shoulder arthroplasties to regain that range of motion in order to live more active lives.
History of shoulder arthroplasty
Joint replacement surgeries date back to the 1800s, with the first arthroplasty being performed in 1821 by a Westminster Hospital, Dr. Anthony White. Shoulder replacement surgery was first performed in the U.S. in the 1950s, and it was used mostly to treat severe shoulder fractures. Use of this procedure, as with other arthroplasties, has grown in recent years, and it's now being used to treat other painful conditions of shoulder, including conditions that cause inflammation of the joints such as arthritis. Shoulder arthroplasty is used often as a last resort when less invasive, more conservative measures do not work, such as NSAIDs (non-steroidal anti-inflammatory drugs) and physical therapy. Today, more than 50,000 patients annually opt for this treatment to restore shoulder and arm range of motion.
Types of shoulder replacement surgeries
There are a few types of shoulder arthroplasties available to patients in the U.S. and worldwide. The type of replacement surgery depends on the patient's age and level of physical activity to restore, the severity of the condition and its location. These include arthroplasty, hemi-arthroplasty, and reverse shoulder arthroplasty.
Total arthroplasty: This type of shoulder replacement surgery involves replacing the head of the humeral bone (the bone that extends from the elbow to the shoulder) with a prosthetic metal ball and the socket area of the glenoid (the cavity in the shoulder blade into which the humeral bone fits) with a prosthetic plastic socket. The surgeon resurfaces both of these bones before inserting the prosthetic materials.
Hemi-arthroplasty: In cases where the glenoid is too broken down, rotator cuff tendons are not adequate, or good cartilage is still present, the surgeon may not replace the socket. In this type of shoulder replacement surgery, only the humeral portion of the shoulder is replaced.
Reverse shoulder arthroplasty: This type of shoulder replacement surgery involves switching the location of the replacement ball and joint. Reverse shoulder arthroplasty is performed for very severe arthritis, rotator cuff tear, or in cases where previous shoulder replacement has failed.
Medical device compliance and regulations
Because shoulder arthroplasty is technically a procedure, it is not regulated by the Food and Drug Administration (FDA). However, the medical devices used to perform this surgery can be, and are, regulated by the FDA. Only FDA-approved medical devices can be used in such shoulder arthroplasties. The FDA also makes statements about the conditions and severities thereof are approved to have these devices used on them. For example, for devices used in reverse shoulder replacements, the medical devices used are generally approved on patients who have gross rotator cuff deficiency. The joint must be structurally and anatomically suited to receive whichever implants are selected, and a functional deltoid muscle is necessary to use the device.
As a number of lawsuits have recently been filed in the United States regarding prosthetic medical devices used in hip replacements, the FDA has been more strictly regulating manufacturers who sell these devices. These regulations also apply to those companies that sell shoulder replacement prosthetics. Under new FDA regulations, manufacturers must include in their applications for approval the results of clinical trials as well as scientific evidence showing these medical devices and the materials used to be safe and effective.
History of shoulder arthroplasty
Joint replacement surgeries date back to the 1800s, with the first arthroplasty being performed in 1821 by a Westminster Hospital, Dr. Anthony White. Shoulder replacement surgery was first performed in the U.S. in the 1950s, and it was used mostly to treat severe shoulder fractures. Use of this procedure, as with other arthroplasties, has grown in recent years, and it's now being used to treat other painful conditions of shoulder, including conditions that cause inflammation of the joints such as arthritis. Shoulder arthroplasty is used often as a last resort when less invasive, more conservative measures do not work, such as NSAIDs (non-steroidal anti-inflammatory drugs) and physical therapy. Today, more than 50,000 patients annually opt for this treatment to restore shoulder and arm range of motion.
Types of shoulder replacement surgeries
There are a few types of shoulder arthroplasties available to patients in the U.S. and worldwide. The type of replacement surgery depends on the patient's age and level of physical activity to restore, the severity of the condition and its location. These include arthroplasty, hemi-arthroplasty, and reverse shoulder arthroplasty.
Total arthroplasty: This type of shoulder replacement surgery involves replacing the head of the humeral bone (the bone that extends from the elbow to the shoulder) with a prosthetic metal ball and the socket area of the glenoid (the cavity in the shoulder blade into which the humeral bone fits) with a prosthetic plastic socket. The surgeon resurfaces both of these bones before inserting the prosthetic materials.
Hemi-arthroplasty: In cases where the glenoid is too broken down, rotator cuff tendons are not adequate, or good cartilage is still present, the surgeon may not replace the socket. In this type of shoulder replacement surgery, only the humeral portion of the shoulder is replaced.
Reverse shoulder arthroplasty: This type of shoulder replacement surgery involves switching the location of the replacement ball and joint. Reverse shoulder arthroplasty is performed for very severe arthritis, rotator cuff tear, or in cases where previous shoulder replacement has failed.
Medical device compliance and regulations
Because shoulder arthroplasty is technically a procedure, it is not regulated by the Food and Drug Administration (FDA). However, the medical devices used to perform this surgery can be, and are, regulated by the FDA. Only FDA-approved medical devices can be used in such shoulder arthroplasties. The FDA also makes statements about the conditions and severities thereof are approved to have these devices used on them. For example, for devices used in reverse shoulder replacements, the medical devices used are generally approved on patients who have gross rotator cuff deficiency. The joint must be structurally and anatomically suited to receive whichever implants are selected, and a functional deltoid muscle is necessary to use the device.
As a number of lawsuits have recently been filed in the United States regarding prosthetic medical devices used in hip replacements, the FDA has been more strictly regulating manufacturers who sell these devices. These regulations also apply to those companies that sell shoulder replacement prosthetics. Under new FDA regulations, manufacturers must include in their applications for approval the results of clinical trials as well as scientific evidence showing these medical devices and the materials used to be safe and effective.