Jack Elliot Zigler (born May 27, 1952 in
Brooklyn
Brooklyn () is a borough of New York City, coextensive with Kings County, in the U.S. state of New York (state), New York. Kings County is the most populous Administrative divisions of New York (state)#County, county in the State of New York, ...
, New York) is a Board Certified
orthopedic surgeon
Orthopedic surgery or orthopedics ( alternatively spelt orthopaedics), is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopedic surgeons use both surgical and nonsurgical means to treat musculoskeleta ...
specializing in spine surgery at the Texas Back Institute in Plano, Texas. He is best known for being the first surgeon to perform a ProDisc
artificial disc replacement surgery in the United States, on October 3, 2001.
Organizations
Since joining the Texas Back Institute in 1996, Zigler has been an international guest lecturer on topics in spinal reconstruction, as well as a
Principal Investigator
In many countries, the term principal investigator (PI) refers to the holder of an independent grant and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often us ...
for the ProDisc artificial disc replacement system's
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA) clinical studies. He is a former Clinical Associate Professor of Orthopaedic Surgery at
University of Texas Southwestern Medical Center
The University of Texas Southwestern Medical Center (UT Southwestern or UTSW) is a public academic health science center in Dallas, Texas. With approximately 18,800 employees, more than 2,900 full-time faculty, and nearly 4 million outpatient vis ...
in Dallas, Texas. He served as President of the American Spinal Injury Association from 2003 to 2005.
Role as ProDisc Principal Investigator
Zigler's role as Principal Investigator for the ProDisc,
Synthes
Synthes Holding AG (formerly Synthes-Stratec) 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 a ...
Spine's artificial disc replacement system, was to monitor all the clinical ProDisc cases done at the Texas Back Institute, and also to serve as a resource to Synthes on questions about cases done at all of the 19 other investigative sites.
On August 14, 2006, the ProDisc-L ("lumbar") Total Disc Replacement was approved by the FDA for use as a treatment for functionally disabling pain from lumbar
degenerative disc disease
Degenerative disc disease (DDD) is a medical condition typically brought on by the normal aging process in which there are anatomic changes and possibly a loss of function of one or more intervertebral discs of the spine. DDD can take place with ...
("DDD"). It was the second device to be approved by the FDA for such a purpose.
As a condition of approval, Synthes Spine is required to conduct a five-year study assessing the long-term safety and effectiveness of the disc. The study will include the 286 patients who participated in the pre-approval clinical trials. The company is also required to complete an annual analysis and report any major adverse events (such as implant breakage, subsidence or expulsion from the disc space). These conditions are similar to those imposed on the Charite artificial disc. Zigler is himself responsible for publication of the national data now that the ProDisc-L has been FDA-approved.
More recently, questions about ethics of surgeon investigators in the Pro Disc study have been raised, specifically in a New York Times article about conflicts of interest related to his Zigler's financial ties, in which it is reported that he invested $25,000 in the company.
[www.nytimes.com 1/30/2008](_blank)
/ref> Since the time of these articles, there has been no substantiation to support the New York Times' allegations, and a follow-up FDA audit of Zigler's ProDisc site prompted by these allegations turned up no evidence of any wrongdoing.
In the media
Zigler has appeared as a guest expert on Orange County News network in Orange County, California, as well as Good Morning Texas, a morning show produced by the ABC affiliate WFAA-TV
WFAA (channel 8) is a television station licensed to Dallas, Dallas, Texas, United States, serving the Dallas–Fort Worth metroplex as an affiliate of American Broadcasting Company, ABC. It is owned by Tegna Inc. alongside Decatur, Texas, Decat ...
in Dallas
Dallas () is the List of municipalities in Texas, third largest city in Texas and the largest city in the Dallas–Fort Worth metroplex, the List of metropolitan statistical areas, fourth-largest metropolitan area in the United States at 7.5 ...
, Texas. He has been consulted numerous times regarding the spinal injuries of such high-profile celebrities as Christopher Reeve
Christopher D'Olier Reeve (September 25, 1952 – October 10, 2004) was an American actor, best known for playing the title character in the film ''Superman (1978 film), Superman'' (1978) and three sequels.
Born in New York City and raised in P ...
and Jason Priestley
Jason Bradford Priestley (born August 28, 1969) is a Canadian actor and television director. He is best known as the virtuous Brandon Walsh on the television series ''Beverly Hills, 90210'' (1990–1998, 2000), as Richard "Fitz" Fitzpatrick in ...
.
Zigler has also been a subject in a New York Times article that raises questions about the ethics of his role as both Pro Disc Investigator as an investor in the company that manufactured the Pro Disc implant.
*Quoted in USA Today article when actor Jason Priestley
Jason Bradford Priestley (born August 28, 1969) is a Canadian actor and television director. He is best known as the virtuous Brandon Walsh on the television series ''Beverly Hills, 90210'' (1990–1998, 2000), as Richard "Fitz" Fitzpatrick in ...
received injuries in a race-car accident
*Quoted in Cnn.com article on actor Christopher Reeve
Christopher D'Olier Reeve (September 25, 1952 – October 10, 2004) was an American actor, best known for playing the title character in the film ''Superman (1978 film), Superman'' (1978) and three sequels.
Born in New York City and raised in P ...
's spinal cord injury
*Quoted in Orthopedic Tech Review's Industry News section about Christopher Reeve's condition
*Recognized in the Miami Project to Cure Paralysis' newsletter, delivering an honor as ASIA President to a fellow scientist, Damien Pearse, PhD
*Quoted on Raleigh-Durham ABC affiliate's website discussing nonfusion surgical devices
Publications
Zigler is a contributing eEditor to ''Spine Trauma'' and ''Spinal Arthroplasty'', authoritative medical textbooks. He has authored over 45 articles and chapters in internationally-read peer-reviewed
Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer revie ...
medical journals and books.
Books
"Spine Trauma" (1998) and "Spinal Arthroplasty" (2005).www.bestwebbuys.com
/ref>
References
External links
Biography on SpineUniverse, a peer-reviewed information database for spine surgery patients
{{DEFAULTSORT:Zigler, Jack
1952 births
Living people
American surgeons