Pittsburgh, Youngstown, Akron, Cleveland and Detroit, the cities of America’s great industrial heartland, were, in 1978, shedding plants and employees like so much excess baggage in a desperate fight for economic survival. Newspaper headlines captured the angst of the moment with the “Pain Index”—which was the rate of inflation added to the rate of unemployment.
The year started in Cleveland with the “blizzard of the century” which blew through these rust belt cities (82 mph wind gusts) leaving 20 foot snow drifts, 60-below wind chills and 51 people dead in and around Cleveland.
The year ended with the city defaulting on $15 million in debt—the first major U.S. city to do so. Cleveland’s police refused to patrol crime hot spots—despite Mayor Dennis Kucinich’s order to do so. Too risky, they said.
And yet, in one of the most dangerous sections of Cleveland, at a hospital named “Charity,” three orthopedic surgeons were planning something that would eventually form the basis and structure of modern spine surgery.
Karl Alfred, Arthur Steffee and Dennis Stuart
Karl Alfred was head of the Orthopedics Department at St. Vincent’s Charity Hospital in one of the more economically distressed and crime ridden sections of Cleveland. Art Steffee was his partner and Dennis Stuart was a resident.
Across town, at the tonier Cleveland Clinic—A. Seth Greenwald, D.Phil.(Oxon), had established one of the early orthopedic laboratory and surgeon education programs in the United States which, with the advent of the Charnley hip and the associated hip arthroplasty procedure, was an increasing popular program among aspiring orthopedic surgeons.
Greenwald, who’d met Charnley, studied hip biomechanics at Oxford, published a seminal paper in Nature on the subject and would later help Maurice Edmond Müller, one of the founders of the AO foundation, establish a comprehensive orthopedic laboratory and training program in Switzerland.
The orthopedics program, at the Cleveland Clinic Foundation (aka: The Clinic), however, was missing one critical element—trauma training.
One of the busiest emergency rooms in the region was at St. Vincent’s Charity Hospital. As Art Steffee himself would later say about Charity Hospital’s neighborhood, “We have bullets flying around here like mosquitos.”
A perfect match evolved. Cleveland Clinic’s orthopedic residents rotated through Charity for trauma training.
Greenwald organized a monthly lecture series, inviting surgeons from all over the United States and Europe, the who’s who of orthopedics at the time, to the Cleveland Clinic, while always including Karl Alfred’s group from Charity—which, as time passed, proved to be an irritant to The Clinic.
As Greenwald’s relationship with The Clinic grew strained, Greenwald began thinking about starting his own laboratory and education institute. He shared his ideas with the Charity group and in 1980, Alfred, Steffee and Stuart made a proposal to support Greenwald’s dream by guaranteeing his salary and rounding up funding beyond his existing National Institutes of Health, Department of Defense and corporate grants for equipment, an animal facility, a cadaver lab, a full biomechanics and fabrication facility, a surgical suite and more.
Greenwald agreed and, in the Spring of 1981, with much fanfare, the Cleveland Research Institute (CRI) was born.
Testing, Training and Fabrication
CRI was an independent corporation housed in a newly remodeled research building adjacent to St. Vincent’s Charity Hospital. Seth Greenwald was Director. Charity President David D’Eramo said at the time, that CRI would “enhance Cleveland’s already superlative medical reputation” by becoming a focal point for ideas and a forum to attract scientists from “near and far.” Good news at a time when Cleveland was better known for unemployment, crime and a river that caught fire.
But one man, above all, would use CRI as the launching pad for the first modern spinal implant company, Acromed, and, using Greenwald’s structure, equipment, and personnel to create the R&D and intellectual property foundation for future spine surgery implants, procedures and instruments.
Arthur Steffee.
Along with his equipment, all of the engineering graduate students and staff from his lab at the Cleveland Clinic followed Greenwald to CRI. James Moran, who would complete his Ph.D. while working at CRI, headed up the engineering staff. Sue Martin administered CRI’s education courses for residents and visiting surgeons. Twenty, thirty or more physicians attended each of the classes. Among the students was a young Gary Michelson, a surgeon who would become one of the most prolific and controversial spinal implant inventors ever.
CRI engineers Andy Cepulo, Jack Geiger, Diane Peterson, Joe Skraba, and Terry Stahurski as well as Eileen Morgan (who was also in charge of the animal lab and assisted in surgery and cadaver labs) joined Greenwald and were integral to the innovative products flowing out of CRI. Jim Berry, who had a master’s in biology, carried out histology and tissue culture work, collaborating on foundational research on the implant-bone interface.
And then there was Frank Janson.
Greenwald literally found him in the Cleveland Clinic’s maintenance department, in the hospital’s basement. Greenwald recalls, “He was quite an adept guy. I liked him a lot. He was a crack machinist. And we produced a lot of equipment together. You didn’t need to give Frank blueprints. In fact, if you gave him blueprints, it got in the way. He had a lot of creative ideas. He developed a lot of the equipment we had in the lab.”
Stahurski recalls, “Frank Janson was brilliant, he could make anything, anything you wanted, and improve it too.”
Indeed, Frank Janson may well be the unsung hero of the first widely commercialized spinal implant: The Steffee Plate. But we are getting ahead of the story.
Spinning Ideas and Concepts
It was the early days of biomedical engineering and there was not really the specialization that exists today…interface experts, biomaterial experts. CRI’s staff each had training in specific areas, but because the lab was dependent on soft money, in order to pay the bills, CRI’s staff took on a wide variety of projects.
As Terry Stahurski recalls: “There was a lot of innovation at CRI. Everyone had 3 or 4 projects going on at any one time. Things that are taken for granted now, were unknown then. The patents and intellectual property were wide open. We were paid next to nothing and one of CRI’s main tenets was to keep one particular surgeon happy, Art Steffee.”
Among the implants, instruments and testing equipment that initiated at The Clinic’s Biomechanics Laboratory and further developed at CRI were:
- A suction lavage machine
- A shoulder resurfacing system including implants and instrumentation
- Testing fixtures and test methods for bovine tendon and ligament xenografts
- Spinal vertebral plates
- A pneumatically powered bone grinder
- A multi-axial wrist replacement
- Novel acrylic bone cement additives as well as antibiotics for use with artificial joints
- Porous surfaces to promote bone growth
- Custom tool modifications for Occupational Therapy
- New testing equipment, fixtures and testing methods for orthopedic tissue
- Ongoing surgical instrument sharpening and repair for the entire hospital
But, perhaps the most enduring aspect of CRI was its commitment to education and training. “We had the residents come through the lab as part of their rotation. They would come up with projects,” remembers Jim Moran. “The younger ones would come in with fresh eyes and they would say ‘Why the heck are you doing that?’ and ‘Could we do this better?’ or ‘This is a problem that I saw in surgery today. Is there something we can do about it?’”
At its peak, between administration, orthopedics, cardiovascular and clinical research coordinating office, CRI had about 35 or 40 employees.
Fabricating an Implant for Steffee DURING Surgery
As Stahurski recalls, “Steffee was always bringing ideas to CRI. He’d say ‘I need a patellar tendon’ or whatever. But you had to watch him because if you had a prototype, he might think it was good enough for implantation.”
One story in particular illustrates CRI’s dynamic, creative, get-it-done culture.
It was Friday afternoon, about 1pm. Dr. Steffee had a patient on the table, sedated and ready to receive an entire, titanium femur replacement. The implant had been fabricated by outside firm Techmedica.
As Steffee tried to lay the implant into the gap he’d created by removing the patient’s femur, he found it wouldn’t fit. Apparently, when Steffee gave the company the dimensions for the replacement part, he’d applied a magnification factor. The company then also applied that same magnification factor—resulting in a too-long implant.
With an open, sedated patient lying on the table, Steffee called Techmedica. What they could do, they said, was fabricate a replacement part, take it to the airport and put it on a plane.
Steffee hung up the phone and ran to CRI.
Frank Janson, Jim Moran, and Jack Geiger broke the task into components and started working in parallel. The center of the implant was hollow, so they cut a section out from the middle. They fabricated a dowel which fit into the hollow core, pinned it across, welded it, bead blasted it and passivated what was now a precisely fitted implant. In less than two hours, start to finish, Janson and his team got the replacement implant up to the operating room.
The following Monday, Dr. Steffee wheeled his femur replacement patient down to the lab to introduce the team to the patient and vice versa.
The First Implanted Artificial Human Vertebra
In 1984, a 54-year-old woman on her way back to Cleveland from a 500-mile driving trip out west, felt a pulling, then an excruciating pain in her back. The cause, she would soon learn, was a spinal tumor which, for her survival, needed to be removed and with it, one of her vertebrae.
She was referred to St. Vincent’s and Dr. Steffee, who was now head of the hospital’s Orthopedics Department.
After reviewing her case, Steffee decided that he and the CRI team could, using the patient’s X-rays to calculate its dimensions, fabricate a prosthetic vertebra which would maintain her spine’s stability and lordotic structure. If he was right, he would be inventing the world’s first vertebral prosthesis.
On October 25, 1985, in a 5-hour operation, which had to be delayed one week while the CRI engineers finished making the implant, Steffee removed the cancerous bone and replaced it with a titanium spacer, two Steffee plates and multiple pedicle screws.
Frank Janson made the implant with design input from Jim Moran and Jack Geiger. Originally Steffee wanted polyethylene plugs in the construct into which he’d insert bone screws. Jim Moran suggested that they, instead, put polyethylene cylinders and that they pre-drill the cylinders to accept the pedicle screw. That way, Steffee could put the screws in and rotate the cylinder within the vertebral body which would let him line the screws up with the two Steffee plates (five or six slots).
The operation was so successful that St. Vincent’s issued a press announcement about this important surgical “first” and asked the patient, Helen Murphy, to describe to the media how she was feeling. She told the reporters, “I was hopeful and confident in the surgery; it was my only chance. It’s hard to believe that the artificial vertebra is really there because I don’t feel it. I was walking a week after surgery and was home in 10 days. It was worth it all just to be able to walk again.”
Helen’s husband, Richard Murphy, praised Dr. Steffee saying, “He gave Helen back her life.”
The Steffee Plate
In 1981, Art Steffee had an idea for a variable screw placement plate and screw system which gave surgeons a comparatively easy way to place bone screws precisely into the center of each pedicle while also providing a way to angulate each screw. The Steffee Plate made configuration of the construct more dependent on the patient’s own spinal anatomy than on the limitations of the plates themselves.
The Steffee Plate would become the first mass commercialized spinal implant and the basis for the first purely spinal implant company—Acromed.
In that post-World War II era, starting with Harrington’s posterior rods, then continuing with Luque’s modifications to the rod and his segmental sublaminal wiring and evolving further with Roy-Camille’s posterior spine plates with transpedicular bone screws, surgery to correct deformity and instability was taking hold, slowly. Patient outcomes, while still hampered by too much pseudoarthrosis, long periods of immobilization and often inadequate decompression, were significantly better than they were pre-World War II.
The Steffee Plate was the game changer that opened up spine surgery as a viable specialty unto itself.
Before the Steffee Plate, surgeons could only insert screws through holes in metal plates. Steffee’s variable screw placement (VSP) system reversed that order. Now, surgeons put the screws in first—at whatever angulation they wanted—then laid the plates over the screws where they’d put a nut over the screw head. Also, instead of holes, the VSP plate had slots which allowed for variability based on the patient’s anatomy. The slots, in turn, had nests which captured and held the nut to the screw.
The VSP screws also had both a cancellous thread section and a machine threaded section for securing the nut. Before this, bone screws were either threaded for cortical (harder) bone or cancellous (softer) bone.
CRI’s engineering team took Art’s vision and added a number of key features. It was, according to those who were there at the time, a collaborative effort. Frank Janson made the first prototypes. Jim Moran led the engineering effort. Joe Skraba did the drawings. And the final VSP system was, in fact, the work product of Steffee, the CRI engineers, and Greenwald together.
One day Steffee literally took the plates, the VSP screws and instrumentation from CRI and in collaboration with Ed Wagner, a venture capitalist and local businessman, started a company named Acromed. Almost simultaneously, he filed for a patent (December 16, 1983) and roughly three weeks later, assigned it to Acromed.
Patent number 4611581 was granted by the U.S. Patent and Trade Office (PTO) on September 16, 1986, naming Steffee as sole inventor. Three years later, March 29, 1989, to be exact, Acromed licensed the Steffee plate to a Memphis-based start-up company named Danek Medical.
Frank Janson, who was not listed on the patent believed that he was, in fact, responsible for Claim 8 of Steffee’s patent (which described a “surface means for engaging said nut [as described in Claim 7] against sidewise movement relative to said plate as said nut rotated to said force transmitting member [pedicle screw].”
Janson then assigned his claimed ownership of patent 4611581 to Danek Medical in 1995. Later that year, Danek filed a petition with the PTO challenging Steffee’s claim that he was sole inventor.
Danek and Janson lost that challenge. On April 12, 1995, the PTO affirmed that Steffee was the sole inventor of the Steffee Plate, patent #4611581.
The End of CRI
Greenwald challenged the unfolding events and was terminated and locked out of CRI in December 1983. All of his grant-purchased equipment which was used to qualify the VSP plates and screws, as well as the library and files brought to CRI at its founding were returned to Greenwald three years later, who was now at Mt. Sinai Medical Center in Cleveland. Art Steffee continued his practice at St. Vincent’s while also launching Acromed.
In retrospect, the beginning of Acromed was the ending of CRI. A lot of the testing that CRI would otherwise have done for Steffee began going to other places. CRI’s finances, which were heavily dependent on government funding, deteriorated. Several CRI engineers left to join Steffee at Acromed.
One person who did not follow Steffee was Jim Moran, who was then appointed Director of Orthopaedic Research at CRI. Today, as he looks back, he notes, “The process worked, we gave life to a very successful company. You would have thought since we helped create the pie, made it grow, we would have gotten a slice. But we didn’t. Maybe we could have been a little bit smarter. But the conflicting interests of CRI, St. Vincent’s, Acromed and Dr. Steffee tied our hands. And the lack of support showed exactly how much we were valued.”
Having said that, Moran remembers his time working with Steffee fondly. “Art Steffee was interesting. Always had a lot of good ideas. If he was doing something and saw that it wasn’t working right, he was the type of person who would recognize that it needed to be improved. Dr. Steffee was a pioneer. You can tell the pioneers because they got the arrows in their back.”
Eventually it become too much of a struggle to keep CRI going and it closed quietly a few years later. Acromed was purchased by DePuy, Inc. in 1998 for $325 million.
|
Seth Greenwald, D.Phil.(Oxon)  Dr. A. Seth Greenwald is currently Director of Orthopaedic Research Laboratories. He is the Founder and now, Emeritus Director, of the prestigious Current Concepts in Joint Replacement meetings. Dr. Greenwald received his doctorate in orthopaedic and engineering sciences from Oxford University, England in 1970 and holds advanced degrees from the Massachusetts Institute of Technology and Columbia University. Dr. Greenwald has received many honors, notably, The American Academy of Orthopaedic Surgeons’ Kappa Delta Award for outstanding orthopaedic basic science research, The Presidential Medal of the British Orthopaedic Association, The SICOT Medal for lifetime contributions to orthopaedic education and research, The Lifetime Achievement Award of the International Society for Technology in Arthroplasty (ISTA). Dr. Greenwald still resides in Cleveland and his influence on the practice of orthopaedics can never be overstated. |
Frank Janson
 Born Franciszek Janik in Germany but raised in Poland, Frank entered military flight school in 1935. He escaped the invading German army, fleeing to Britain where he joined the RAF and was one of the pilots in the Battle of Britain. He was part of the 300th, 301st and 302nd squadrons. Between 1940 and 1943 he flew nonstop. For his service, he received the Distinguished Flying Medal (Britain), the Order of Virtuti Militari (Poland) and other decorations. His many contributions to medicine include advancement of kidney dialysis, thoracic and orthopedic surgery, the first total vertebral replacement and the Steffee Plate. Of the seven men from his hometown to serve in World War II, Frank was one of only two who survived. He died at age 92 in 2012 in Trinity, Florida. |
