SANTA
ANA, Calif. - Joints creak. Hips give out. Backaches become
unendurable.
Who ya gonna
call?
Not a
superstar doctor. Instead, a reliable orthopedic expert.
Orthopedic
surgeons don't get the glory that goes to heart surgeons and
brain surgeons, but people depend on them when age or injury
make movement painful.
Innovations,
as befit such a craftsmanlike medical specialty, tend to
come in dibs and drabs, not in dramatic breakthroughs.
"Innovations
have been incremental changes - and not necessarily
improvements," veteran orthopedic surgeon Dr. Harry
Skinner told the American Society of Mechanical Engineers at
a conference about medical devices last month in Irvine,
Calif.
His talk,
which focused on joint repairs, was followed a week later by
a corporate presentation to the Southern California
Biomedical Council on products for fixing deteriorating
spines.
Together, the
talks summarized the state of the orthopedic art and
highlighted the work of several local innovators.
In an
orthopedic market that's expected to reach $20 billion
within a few years, no local company comes close to
dominating the field like artificial-joint makers Zimmer of
Indiana or Stryker of Michigan.
About 15
small entrepreneurial companies make new varieties of
orthopedic devices in Los Angeles and Orange Counties, said
Ahmed Enany, president of the SoCalBio trade group.
In Orange
County, spinal devices are a particular specialty.
FRACTURES
Treatment for
broken bones has improved just a bit in the past 20 years,
said Skinner, who is a medical textbook author and
plain-talking veteran of 12 years as chairman of the
Department of Orthopedic Surgery at the University of
California-Irvine School of Medicine. He moved to St. Jude
Medical Center in Fullerton last year after UCI replaced him
with a new department head.
"Twenty
years ago we had bone plates" to hold fractured bones
in place, he said. "Now we have individualized fracture
plates. "
"That's
an incremental advance. It isn't a home run."
The top
innovations, he said, are "locking plates" for
repairing fractures.
The surgeon
can attach screws into those plates to hold fragmented bones
in place, eliminating the need to rely for support on screws
attached to the bone itself.
SPINE
Several
orthopedic companies focus on spinal repair devices,
including Interventional Spine of Irvine, Allez Spine of
Irvine, and VertiFlex of San Clemente.
Interventional
Spine makes two implants that doctors can attach via
minimally invasive surgery to strengthen the lower spine.
The company's
Perpos system, which is on sale in Europe and the United
States, uses screws to compress part of the backbone in
connection with a spinal fusion procedure. The related
PercuDyn system also strengthens the spine but allows more
movement. It's used in Europe, and the company this week won
approval from the Food and Drug Administration to start
clinical trials in the United States.
Allez Spine,
which is owned by doctors, makes the Laguna Polyaxial
Pedicle Screw System, which can immobilize injured or
deteriorated portions of the spine with a rod attached to
vertebrae by titanium screws. Allez has been hit with a
patent-infringement lawsuit from large spinal-device
companies Medtronic and Johnson & Johnson, as well as
criticism from industry groups and regulators that its
doctor-owners have financial incentives to use Allez
products that might not be in their patients' interest.
VertiFlex
makes implants such as the Silverbolt and the Dynabolt for
minimally invasive spinal fusion and for strengthening the
spine while allowing mobility.
BONE
INFECTIONS
Orthopedic
infections are tough to get rid of, Skinner said. In
contrast to infections in soft tissue, which antibiotics
typically can clear up in two weeks, infections in bones and
joints often require six weeks of antibiotics to eliminate.
"It's a
huge expense," he said, costing $50,000 and occurring
in roughly one of every 100 patients.
He criticized
Medicare for its plan to stop reimbursing hospitals for the
cost of treating infections that patients pick up while
hospitalized.
"It's
not rational," he said. "I'm going to have
post-operative infections as long as patients come to me
with bacteria, and every one of us has bacteria – in the
gut and elsewhere."
To cut down
on infections, he proposed bacterial-repellent surfaces on
prostheses, better methods of closing up surgery sites, and
more automated intravenous systems for antibiotics.
SHOULDERS
Without the
day-in, day-out pressures that hips and knees undergo,
shoulders less frequently need to be replaced. The number of
shoulder replacements is about one-twentieth the number of
knee replacements.
A recent
innovation in that field is so-called "reverse shoulder
replacement surgery," which is used for patients with
severely malfunctioning joints. Unlike a natural shoulder
joint, which consists of a ball at the end of the arm bone
and a socket on the shoulder bone, the reverse-design
implant has a socket on the arm bone and a ball on the
shoulder bone.
In Orange
County, Calif., the procedure is done at St. Jude in
Fullerton and St. Joseph Medical Center in Orange, Skinner
said.
HIPS AND
KNEES
Knee
replacements are tops in the orthopedic world, with about
529,000 performed annually in the United States at an
overall cost of $3.2 billion.
Hip
replacements are also popular, totaling 250,000 a year and
costing $1.8 billion.
As the
population grows older, the need for such operations will
increase.
For example,
surgeons will perform an estimated 2.5 million knee
replacements annually by the year 2028, Skinner said.
Despite their
popularity, joint replacements haven't improved much in
recent years, Skinner said.
Companies
have introduced longer-lived polyethylene plastic-on-ceramic
joints as an alternative to the polyethylene
plastic-on-metal cobalt chrome joints that Skinner called
the "gold standard."
The ceramic
joints are expected to have roughly a 25-year life, compared
with about 15 years for metal joints, but they have
drawbacks.
"Ceramic
is kind of like dinnerware. It fractures
catastrophically," Skinner said.
Some patients
also report problems with ceramic hips that squeak,
including a man who complained that his wife would always
laugh at the squeaks his hip made when they made love,
Skinner said.
Other
innovations include the use of magnetized materials to keep
joint components separated, ceramic-on-ceramic joints, and
metal-on-metal joints.
Overall, the
innovations mostly amount to "changes, but not
improvements," he said.
"Device
manufacturers, like Ford and Chevy, need a new model every
year to maintain profits."