Intervertebral disc arthroplasty
| Intervertebral disc arthroplasty | |
|---|---|
| Intervention | |
| ICD-9-CM | 80.5 |
Artificial disc replacement (ADR), or total disc replacement (TDR), is a type of arthroplasty. It is a surgical procedure in which degenerated intervertebral discs 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.
Regulation
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 Synthes 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.[1]
The Maverick, manufactured by Medtronic, has been prevented from entering the US market due to patent infringement litigation, ongoing as of September, 2010.[2]
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 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,[3] the disc received FDA approval in the United States in October 2004, following a four-year clinical trial. One of the worldwide practicing artificial disk replacement is the pioneer drs.Willem Zeegers since 1989. Drs. Willem Zeegers stopped with the Carité and is performing the lumbar Activ L artificial disc replacement (company Aesculap)since 2005.
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, after visiting drs.Willem Zeegers in the Netherlands, who showed him his experience with the Charité artificial disc implantation in the neighties. Drs Zeegers was involved in the evolutionary development of the Activ L instrumentation and Activ L implant design.
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.[4] Questions have been raised about the accuracy of that article.[5]
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.[6]
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.[7]
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 manufacturers.
There are several class-action lawsuits pending[8] against the Charite Artificial Disc, and reports of complications with the Pro Disc Artificial Disc implant when used in certain surgical situations.[9][10]
Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients.==References==
- ↑ "http://www.cms.hhs.gov/EOG/downloads/EO%200051.pdf"|CMS
- ↑ "MASS Device, Federal appeals court hands Medtronic a win in Spine Solutions infringement lawsuit".
- ↑ Charite Artificial Spine Disc Replacement
- ↑ Abelson, Reed (January 30, 2008). "Financial Ties Are Cited as Issue in Spine Study". The New York Times. Retrieved May 5, 2010.
- ↑ "A Fatally Flawed NY Times Article".
- ↑ "AAOS, Aching backs get support from FDA, but not payors".
- ↑ "WebMD article, Spinal Fusion (Arthrodesis)".
- ↑ J&J Discs Face Backlash | Melissa Davis | JNJ MDT SYK - TheStreet.com
- ↑ Journal of Spinal Disorders & Techniques - Abstract: Volume 18(5) October 2005 p 465-469 Vertical Split Fracture of the Vertebral Body Following Total Disc Replacement Using ProDisc: Report of Two Cases
- ↑ Spine - Abstract: Volume 30(11) June 1, 2005 p E311-E314 Bilateral Pedicle Fractures Following Anterior Dislocation of the Polyethylene Inlay of a ProDisc(R) Artificial Disc Replacement: A Case Report of an Unusual Complication