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| == Role as ProDisc Principal Investigator == | == Role as ProDisc Principal Investigator == | ||
| Zigler's role as ''']''' for the ProDisc, Synthes Spine's ], 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. | Zigler's role as ''']''' for the '''ProDisc''', Synthes Spine's ], 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 U.S. Food and Drug Administration for use as a treatment for functionally disabling pain from lumbar degenerative disc disease ("DDD"). It was the second device to be approved by the FDA for such a purpose. | On August 14, 2006, the '''ProDisc-L''' ("lumbar") Total Disc Replacement was approved by the U.S. Food and Drug Administration for use as a treatment for functionally disabling pain from lumbar degenerative disc disease ("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. | 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. | ||
| == Publications == | == Publications == | ||
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Personal life
Dr. Jack Elliot Zigler, M.D. (May 25, 1952 - ?) was born in Brooklyn, New York, to Irving and Florence Zigler. He is a Board Certified orthopedic surgeon 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.
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 for the ProDisc artificial disc replacement system's FDA clinical studies. He remains a Clinical Associate Professor of Orthopaedic Surgery at UT Southwestern School of Medicine in Dallas, Texas.
Zigler currently resides in Dallas, Texas, with his wife Wendy, and his children, Jeffrey and Jennifer.
Education/Distinctions
In 1973, Zigler received a B.S., with distinction, from Cornell University. He received an M.D. in 1977, cum laude, from SUNY Upstate Medical University in Syracuse, New York. After a Surgical Residency at Long Island Jewish - Hillside Medical Center, Zigler completed his Orthopedic Surgery Residency at Mount Sinai School of Medicine. Finally, Zigler completed a Fellowship in Spine Surgery and Spinal Trauma at Case Western Reserve University School of Medicine in Cleveland, Ohio.
In 1981, Zigler was named Chief Resident at Mount Sinai School of Medicine. During the 1980's, he served as Chief of the Spinal Injury Service and Director of Fellowship and Residency Training at Rancho Los Amigos National Rehabilitation Center in Los Angeles, California. While performing his duties there, he also served as Clinical Professor of Orthopedic Surgery at the University of Southern California School of Medicine. In 1984, Zigler served as the Spinal Injury Consultant to the Los Angeles Olympic Games.
Role as ProDisc Principal Investigator
Zigler's role as Principal Investigator for the ProDisc, Synthes 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 U.S. Food and Drug Administration for use as a treatment for functionally disabling pain from lumbar degenerative disc disease ("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.
Publications
Zigler is a Contributing Editor to Spine Trauma, as well as Spinal Arthroplasty, both authoritative medical textbooks. He has authored over 45 articles and chapters in internationally-read peer-reviewed medical journals and books.
Professional Organizations
American Spinal Injury Association, Board of Directors, President Emeritus
• Cervical Spine Research Society, Executive Committee • American Academy of Orthopedic Surgeons, COMSS Representative • North American Spine Society, Chairman of Task Force on Aging • American Orthopaedic Association
See also
Books
"Spine Trauma" (1998) and "Spinal Arthroplasty" (2005) on sale
External links
- Biography on Texas Back Institute's website
- Biography on Spine-Health, a peer-reviewed information database for spine surgery patients.
- Biography on SpineUniverse, a peer-reviewed information database for spine surgery patients.
- CSRS Author, "Patient Information Sheet on Cervical Fusion Materials"