Five years ago, Jimmie Johnson, a West Palm Beach bricklayer, fell 22
feet off a construction site ladder and landed upright, shattering bones in
his feet, ankles and legs.
Even after several corrective surgeries, the pain ``felt like someone
sticking an ice pick in and out of my ankles,'' he says.
Desperate, Johnson, 44, considered amputation. Instead, he said yes to an
ankle prosthesis, available in this country only since last October.
Performing the operation was Mark Feldman, a Miami Lakes podiatric surgeon,
one of four doctors nationally to give patients a new ankle using this
device.
Today, Feldman is pioneering a technique that many see as a big part of
medicine's future: When a body part wears out, you replace it.
In the case of the ankle prosthesis, the replacement helps those with
rheumatoid arthritis, a crippling joint condition, or arthritis that results
from a broken ankle. But before approving the device for widespread use, the
Food and Drug Administration requires testing, which involves doctors,
including Feldman, performing multiple surgeries.
Though knee and hip replacements are decades old, ankle replacement is
relatively new. No one knows how long it can last or what long-term
complications lie ahead.
``We still need more research on it,'' says Jerry D'Alessio, applications
engineer for Endotec, the South Orange, N.J., company that manufactures the
device. ``What we have now isn't adequate for FDA approval.''
Based on European studies, the failure rate is about 3 to 5 percent.
Complications include the implant shifting, which could require repeat
surgery. If the bone is too soft, the surgery can't be done at all and ankle
fusion is the only option.
In the past, those with mangled ankles often did have their bones fused, a
procedure in which the surgeon removes the ankle joint and connects the foot
to the leg. The result was painful and left patients limping.
In contrast, when the ankle replacement is successful, people who once
limped along painfully can walk comfortably, climb stairs, play golf and hike.
But more vigorous activities such as running, tennis or skiing, which heavily
stress the ankle, are discouraged.
``Remember, it's a prosthesis,'' Feldman says. ``It's not your real ankle.
We don't know what the life span is.''
Device looks simple
For something that replaces the complex ankle, the three-piece device looks
deceptively simple.
One piece, shaped like a short finger, connects to a leg bone. A second
piece, shaped like an upside-down bowl, connects to a foot bone. Between those
two pieces, a small polyethylene square fits into the grooved bowl and moves
forward and backward, allowing the foot to move naturally.
The finger- and bowl-shaped pieces are made of titanium, which the body
doesn't reject, and are covered with tiny titanium beads. Within six weeks,
new bone growth meshes with those beads, allowing patients to put their full
weight on their foot again.
The surgery takes about 90 minutes for those with rheumatoid arthritis
because the bone is soft. But for old fractures, where lots of bone must be
cut away, surgery can range from two to four hours.
Medicare, which approves the procedure, pays between $12,000 to $15,000 for
hospital costs. Feldman's fee is between $5,000 and $10,000 depending on the
ankle's condition. Many, but not all, insurance plans cover the charges.
After a four-day hospital stay, patients wear a toe-to-knee cast for six
weeks, then go through physical therapy for one to two months.
``Over time, the muscles and tendons have shrunk,'' Feldman says.
``Patients have to learn to walk again in a normal way.''
In spite of surgery on his right ankle in March, Johnson, the bricklayer,
still has pain. But it's half what it was before the replacement.
``And I can walk more now,'' he says. ``Before, I walked from one end of
the house to the other and had to sit down, the pain was so bad. Now, I can
walk the dog around the block.''
`I already feel less pain'
For years, Louis Cohen, 72, had enjoyed walking 2 or 3 miles a day near his
Lauderdale Lakes home for exercise. But his ankles were always weak, and over
the decades he's twisted them hundreds of times.
Within the last year, sharp, shooting pains moved into his left ankle, and
he could no longer walk any distance. A couple of doctors suggested fusion. He
choose ankle replacement instead.
``It's been one week since I had surgery, and I'm still in a cast,'' says
the retired insurance agent. ``But I already feel less pain than I did
before.''
Fixing shattered ankles is no easy feat. Though successful hip replacements
have been available for roughly 40 years and knees for about 30, ankles remain
a problem. That's because they perform a big job bearing your weight in a
small space.
When you take a step, your ankles support five times your body's weight,
compared to the hip and knee, which support twice your body weight, Feldman
says.
During his 28 years as a podiatric surgeon, Feldman followed the research,
waiting for a workable ankle replacement. During the '70s, as many as eight
prostheses were used, none a good fit. A few were cemented in place, resulting
in a rigid prosthesis.
``Your ankle has to move,'' he says. ``If a prosthesis is rigid, it's
eventually going to break.''
One five-year study done during the '70s revealed a failure rate of more
than 50 percent, primarily because of poor design and the cement problems. As
a result, doctors abandoned most of these prostheses in the United States.
By the mid-1980s, a New Jersey doctor, Fred Buechel, and an engineer,
Michael Pappas, created the ankle replacement that bears their names: the
Buechel-Pappas Total Ankle Replacement. (Two other companies also make ankle
replacements, one similar to the Buechel-Pappas, the other with a middle
portion that's fixed, rather than mobile.)
During the past 21/2 years, Feldman participated in about 30 surgeries in
Europe using the Buechel-Pappas model, which has been available abroad for
nearly 15 years. About 80 percent of the patients who have lived with it for
10 years remain pain-free, Feldman says.
FDA investigation
Back in the states, Feldman became part of the Food and Drug
Administration's investigation, which started last fall. It eventually will
involve about 10 doctors nationwide, mainly orthopedic surgeons.
Many patients in the FDA investigation will be followed for two years after
their surgery, says D'Alessio, who works for the manufacturer. So FDA
approval, if it comes, could be five years away. At that point, the prosthesis
will become widely available.
The number of patients who might take advantage of the surgery isn't known.
But 20,000 people in the United States break their ankles each year, Feldman
says. He estimates that 25 percent develop painful arthritis. An additional
2.1 million Americans have rheumatoid arthritis, though figures on how many
need ankle replacements aren't available.
So far, Feldman, who does the procedure at Parkway Regional Medical Center
in North Miami Beach and Hialeah Medical Center, has done 22 surgeries locally
all successful so far, he says. His patients have ranged in age from 29 to
83.
For Johnson, who was disabled after the fall from the ladder, the surgery
offered much-needed relief.
``It's given me a better quality of life,'' he says. ``Today, I can walk
around without my head shooting off my shoulders from the pain.''
Connecting a new ankle bone.
