Intervertebral disc arthroplasty
Encyclopedia
Artificial Disc Replacement (ADR), or Total Disc Replacement (TDR), is a type of arthroplasty
. It is a surgical procedure in which degenerated intervertebral disc
s in the spinal column are replaced with artificial devices in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain
and cervical pain resulting from degenerative disc disease
.
Artificial disc replacement has been developed as an alternative to spinal fusion
, with the goal of pain reduction or elimination, while still allowing motion throughout the spine. Another possible benefit is the prevention of premature breakdown in adjacent levels of the spine, a potential risk in fusion surgeries.
for use in the lumbar spine and cervical spine. They are FDA approved for one-level applications, after clinical trials were said to show patient improvement in motion and pain equivalent to spinal fusion. Two-level disc replacement surgery is considered experimental in the United States, but has been performed in Europe for many years.
While these two discs have received FDA approval, some insurance companies in the United States do not cover the surgery, still classifying it as experimental. Effective August 14, 2007, the Centers for Medicare & Medicaid Services (CMS) will not cover Lumbar Artificial Disc Replacement (LADR) for patients over the age of 60, on a national basis. Individual localities regulate the use of the procedure in patients 60 and under.
The Maverick, manufactured by Medtronic
, has been prevented from entering the US market due to patent infringement litigation, ongoing as of September, 2010.
The first device approved for use in the United States
was the Charite artificial disc. Invented at Charite University Hospital in Berlin in the mid-1980s by the East German scientist, two-time Olympic
champion in women's artistic gymnastics
Karin Büttner-Janz
and Kurt Schellnack, the disc received FDA approval in the United States in October 2004, following a four-year clinical trial.
The first surgeon to perform a Charite artificial disc surgery in the United States was Scott Blumenthal, M.D., a spine surgeon at Texas Back Institute in Plano, Texas. Blumenthal served as principal investigator for the Charite study in the US.
Dr. Rudolf Bertagnoli helped to develop Pro Disc and its surgical technique in Europe and has taught more than 2,500 surgeons how to perform the procedure.
A statement issued by The American Association of Orthopaedic Surgeons (AAOS) recommends caution in using the new devices, as the studies behind their approval were not designed to show their superiority, only that they produced results equivalent to existing treatments. The data shows that artificial disc replacement patients, when compared to spinal fusion patients, have a shorter recuperation period following surgery, but research also shows that spinal fusion patients show no better outcomes than patients undergoing physical therapy.
The AAOS also states that disc replacement requires a high level of technical skill for accurate placement, and has a significant level of risk if revision surgery is needed.
Members of AAOS and the American Association of Neurological Surgeons joined together as the Association for Ethics in Spine Surgery, formed to raise awareness of the ties between physicians and device manufactureres.
There are several class-action lawsuits pending against the Charite Artificial Disc, and reports of complications with the Pro Disc Artificial Disc implant when used in certain surgical situations.
Arthroplasty
Arthroplasty is an operative procedure of orthopedic surgery performed, in which the arthritic or dysfunctional joint surface is replaced with something better or by remodeling or realigning the joint by osteotomy or some other procedure.-Background:Previously, a popular form of arthroplasty was...
. It is a surgical procedure in which degenerated intervertebral disc
Intervertebral disc
Intervertebral discs lie between adjacent vertebrae in the spine. Each disc forms a cartilaginous joint to allow slight movement of the vertebrae, and acts as a ligament to hold the vertebrae together.-Structure:...
s in the spinal column are replaced with artificial devices in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain
Low back pain
Low back pain or lumbago is a common musculoskeletal disorder affecting 80% of people at some point in their lives. In the United States it is the most common cause of job-related disability, a leading contributor to missed work, and the second most common neurological ailment — only headache is...
and cervical pain resulting from degenerative disc disease
Degenerative disc disease
Degeneration of the intervertebral disc, often called "degenerative disc disease" of the spine, is a condition that can be painful and can greatly affect the quality of one's life...
.
Artificial disc replacement has been developed as an alternative to spinal fusion
Spinal fusion
Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to join two or more vertebrae. Supplementary bone tissue, either from the patient or a donor , is used in conjunction with the body's natural bone growth processes to fuse the vertebrae.Fusing of the...
, with the goal of pain reduction or elimination, while still allowing motion throughout the spine. Another possible benefit is the prevention of premature breakdown in adjacent levels of the spine, a potential risk in fusion surgeries.
United States
Two artificial discs have been approved by the FDA for use in the US: the Charite, manufactured by DePuy for use in the lumbar spine; and the ProDisc, manufactured by SynthesSynthes
Synthes Holding AG is a multinational medical device manufacturer based in Solothurn, Switzerland and West Chester, Pennsylvania, United States. It is the world's largest maker of implants to mend bone fractures, and also produces surgical power tools and advanced biomaterials...
for use in the lumbar spine and cervical spine. They are FDA approved for one-level applications, after clinical trials were said to show patient improvement in motion and pain equivalent to spinal fusion. Two-level disc replacement surgery is considered experimental in the United States, but has been performed in Europe for many years.
While these two discs have received FDA approval, some insurance companies in the United States do not cover the surgery, still classifying it as experimental. Effective August 14, 2007, the Centers for Medicare & Medicaid Services (CMS) will not cover Lumbar Artificial Disc Replacement (LADR) for patients over the age of 60, on a national basis. Individual localities regulate the use of the procedure in patients 60 and under.
The Maverick, manufactured by Medtronic
Medtronic
Medtronic, Inc. , based in suburban Minneapolis, Minnesota, is the world's largest medical technology company and is a Fortune 500 company.- History :...
, has been prevented from entering the US market due to patent infringement litigation, ongoing as of September, 2010.
History
Artificial disc surgery is still relatively new in the United States, but has been used in Europe for more than 15 years.The first device approved for use in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
was the Charite artificial disc. Invented at Charite University Hospital in Berlin in the mid-1980s by the East German scientist, two-time Olympic
Olympic Games
The Olympic Games is a major international event featuring summer and winter sports, in which thousands of athletes participate in a variety of competitions. The Olympic Games have come to be regarded as the world’s foremost sports competition where more than 200 nations participate...
champion in women's artistic gymnastics
Artistic gymnastics
Artistic gymnastics is a discipline of gymnastics where gymnasts perform short routines on different apparatus, with less time for vaulting . The sport is governed by the Federation Internationale de Gymnastique , which designs the Code of Points and regulates all aspects of international elite...
Karin Büttner-Janz
Karin Büttner-Janz
Karin Büttner-Janz Karin Büttner-Janz Karin Büttner-Janz (born 17 February 1952 in Hartmannsdorf a district of Lübben (Spreewald), German Democratic Republic (GDR, commonly:East Germany) is a medical doctor, Olympic medal winner in artistic gymnastics and, since March 1990, chief physician of...
and Kurt Schellnack, the disc received FDA approval in the United States in October 2004, following a four-year clinical trial.
The first surgeon to perform a Charite artificial disc surgery in the United States was Scott Blumenthal, M.D., a spine surgeon at Texas Back Institute in Plano, Texas. Blumenthal served as principal investigator for the Charite study in the US.
Dr. Rudolf Bertagnoli helped to develop Pro Disc and its surgical technique in Europe and has taught more than 2,500 surgeons how to perform the procedure.
Controversy
The New York Times, January 2008, raised concerns relating to the transparency of research being carried out by investors in Prodisc. Questions have been raised about the accuracy of that article.A statement issued by The American Association of Orthopaedic Surgeons (AAOS) recommends caution in using the new devices, as the studies behind their approval were not designed to show their superiority, only that they produced results equivalent to existing treatments. The data shows that artificial disc replacement patients, when compared to spinal fusion patients, have a shorter recuperation period following surgery, but research also shows that spinal fusion patients show no better outcomes than patients undergoing physical therapy.
The AAOS also states that disc replacement requires a high level of technical skill for accurate placement, and has a significant level of risk if revision surgery is needed.
Members of AAOS and the American Association of Neurological Surgeons joined together as the Association for Ethics in Spine Surgery, formed to raise awareness of the ties between physicians and device manufactureres.
There are several class-action lawsuits pending against the Charite Artificial Disc, and reports of complications with the Pro Disc Artificial Disc implant when used in certain surgical situations.