Evoked EMG Testing of Pedicle Screws
Dr. Nathan H. Lebwohl presented this technique of pedicle screw testing, developed in collaboration with neurophysiologist Dr. Blair Calancie at the 1991 annual meeting. Direct palpation of the pedicle track with an electrified probe before placement of the screws was an even more sensitive way of identifying breaches in the pedicle. In the era before intraoperative CT, and computer guided navigation, this became a popular method of identifying malpositioned screws in the operating room.
First anterior dual rod instrumentation for treatment of scoliosis was introduced by Dr. Kiyoshi Kaneda.
The Origin of IMAST
Munich Germany—July 1–2, 1994
1st American-European Meeting on Pedicle Fixation of the Spine & Other Advanced Techniques. This meeting later became known as the International Meeting on Advanced Spine Techniques (IMAST)
The first Steel Lecture was given by Dr. Howard H. Steel at the 29th SRS Annual Meeting in Portland, OR, USA. The lecture was titled, “Discoveries, Inventions and Other Things.”
SRS Annual Meeting, Portland, OR — Prof. Se-Il Suk and colleagues present “Segmental Pedicle Screw Fixation in the Treatment of Thoracic Idiopathic Scoliosis”. This study demonstrated the safety and effectiveness of pedicle fixation in the thoracic spine.
Pedicle Screw Litigation
From 1994 until 1999, this issue was omnipresent, draining much time and effort for the presidents and the Board of Directors from other important educational and societal issues, and threatening the continuing existence of the SRS. Even though pedicle screws had been used for a number of years successfully and safely in other countries, in the United States the Food and Drug Administration (FDA) classified pedicle screws as a Class III device that was not approved by the FDA for general use. Although American spinal surgeons used pedicle screws in some cases in an “off-label” fashion (which exists for many devices or medications not approved by the FDA for a specific purpose), plaintiff attorneys seized an opportunity to blame postoperative problems of adults with spinal surgery for back and leg pain on the use of pedicle screws for the fusion surgery. A multitude of lawsuits resulted against spinal surgeons, many of whom were our SRS members. The SRS and other organizations were named as defendants in this legal action for teaching techniques of pedicle screw use. A major concern of the SRS was that the endowment fund of a few million dollars established for research support could potentially be at risk if a monetary judgment were made against SRS for teaching methods of pedicle screw instrumentation. Other associations involved in this litigation included the American Academy of Orthopaedic Surgeons (AAOS) and American Association of Neurological Surgeons (AANS). Class action suits were brought, including those from Citizens Against Pedicle Screws (CAPS) who advertised in newspapers to recruit patients who had been treated with pedicle screws as a part of their spinal disorder treatment to join their legal action. This litigation dragged on for years. Some spinal implant companies arranged for monetary settlements while others mounted legal defenses. In the end, the class action suits were resolved with no payment from SRS and the pedicle screws were reclassified to a Class II device by the FDA. It is well known that the use of pedicle screws for spinal deformity correction has exploded in the United States since that time with the recognition of the improved and safe spinal deformity correction obtained with this technique.
This pedicle screw litigation was, at least in part, responsible for the establishment of the International Meeting of Advanced Spine Techniques (IMAST), which in 2015 had its 22nd meeting. The 1st IMAST in 1994 was held to teach attendees spine surgery techniques that could not be taught in the US due to this FDA restriction. Prior to the establishment of IMAST, there was a SRS-NASS Pedicle Screw Fixation Course, but NASS elected not to be part of the IMAST meeting established by the SRS to be held outside the United States. IMAST has grown to be an important component of the SRS educational program. While all the presidents and BODs during this five year period of active pedicle screw litigation also attended to the educational and research aspects of the SRS, the favorable decision in 1999, which completely closed the pedicle screw litigation issue, allowed SRS to more productively expend our energy on improving and growing multiple aspects of SRS.