Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, December 26, 2011

New Joints Don't Always Last

(LINK) New Joints Don't Always Last.
New joints don't always last
Those who endure the pain leading to hip or knee replacement know they eventually might have to do it all over again.
Baby boomers are growing old. Obesity is an increasing problem, putting stress on joints. Consequently, the need has increased for what once was a niche in surgery: redoing hip and knee replacements.

Surgeons have had good results with joint replacements in senior citizens, so younger patients with bad joints are more and more likely to undergo replacement surgery, too. And the longer an artificial joint is in place, the more likely it will have to be redone. There's no such thing as a permanent repair.
Several hundred thousand knees and hips are replaced each year in the United States. Sometimes the hardware loosens or breaks down. Sometimes remaining bone wears down and cracks. Sometimes infection requires a redo.
Asked when revisions started to become a booming part of surgery, Dr. Todd Sekundiak at Creighton University Medical Center gave a short answer: "Now."
Hip and knee replacements, and the redos sometimes required, have become so common that a medical journal last year warned there might not be enough surgeons to meet demand five years from now.
Sekundiak, 48, said he does about 600 hip and knee replacement surgeries a year, and 30 percent to 40 percent are revisions. Typically, they are referrals from other clinics and towns. While many surgeons do first-time hip and knee replacements, fewer do revisions because they can be complex and risky.
"Historically, revisions were just kind of a niche market," Sekundiak said. This year he added a partner, Dr. Ian Weber, to help with the demand for replacements and revisions.
Dr. Kevin Garvin also performs revision surgeries. "I've hired two partners in the last three years," said Garvin, chairman of orthopedic surgery at the University of Nebraska Medical Center. Garvin said he and his partners do 750 to 1,000 hip and knee replacements a year, and about 20 percent are redos.
Leland Greving of Central City, Neb., sat with his wife, Shirley, in Sekundiak's west Omaha office one recent morning, hoping their winter plans weren't about to be dashed.
Sekundiak performed hip revision surgery on Greving, 79, in late October. Greving knows the operations can go awry. He had his first hip replacement in 2000 and it had to be redone in 2002. He had trouble with that revision and was referred to Sekundiak this year.
The Grevings went to his office Wednesday for the first follow-up appointment. They hoped to hear from the surgeon that Greving had recuperated enough for them to go ahead with their annual winter retreat to Texas.
"I want to travel and walk when we take vacations and stuff," the retired farmer said before Sekundiak walked in the room.
"We're anxious about it," his wife said. "We want to go to Texas."
Sekundiak sees the anxiety on his patients' faces all the time. They've undergone surgery they hoped would cure their problem. Usually it does. But sometimes the pain returns and the cutting must occur again.
"They're demoralized. They're debilitated," Sekundiak said of many patients who have to undergo redos. "And so the level of anxiety is high. The level of stress is high. And for us, too, because your heart yearns for them."
Dr. Nicolas Noiseux, an orthopedic surgeon at the University of Iowa, said that in patients 55 and older, 80 percent of knee replacements work well for the first 20 years. The percentage is higher for hip replacements.
But Noiseux tells 40-year-old patients receiving a replacement that there's a 100 percent chance they'll need a redo if they live to old age.
Surgeons began replacing hip and knee joints in large numbers in the 1970s. Senior citizens usually received the implants, which proved so successful that younger patients began undergoing the surgery. The numbers will shoot up dramatically over the next few decades.
A 2007 article in the Journal of Bone and Joint Surgery estimated that first-time hip and knee replacements would increase from about 660,000 in 2005 to 4 million in 2030. The number of revisions may rise from close to 80,000 in 2005 to about 365,000 in 2030.
Revisions are harder to do than first-time replacements in many cases. "They can be very simple," UNMC's Garvin said. "But they can be very complex."
Some revisions involve removing only the implanted hip socket liner and the ball that fits into the socket. Others require the surgeon to delicately chisel bone from rods before he removes everything that was put in the first time. Then new rods, cables, screws and other material must go in.
The redos can take several hours to perform and, because of their complexity, involve higher risk of medical complications such as infection and pneumonia.
Surgeons doing revisions sometimes have little bone to work with. Bones can be thin or damaged from prior surgery or trauma.
Microscopic particles caused by friction between the artificial ball and socket can lead to an immune-system response that diminishes bone in the area.
They may use bone grafts or artificial pegs and devices to bulk up the area. Ultimately, surgeons want the bone to grow into the implants. This process can be promoted by coating implants with calcium or manufacturing them with tiny pores into which bone grows. The technology and implants have improved over time.
Still, implanted materials sometimes are recalled by manufacturers because they don't meet expectations. A recall may require removal of implants, but not necessarily.
Patients are encouraged to get up and start walking soon after revision surgery because bone is living tissue, and walking helps bone in the hips and knees to strengthen and thicken.
If bone doesn't grow into the implant, the artificial material loosens, and the surgery must be redone.
Sekundiak, a Canadian who trained in Phoenix and Chicago and practiced in Winnipeg and at the Nebraska Medical Center before joining Creighton, said he receives referrals from throughout the Midwest.
He said a first-time hip replacement may cost around $20,000, while a redo can cost more than $100,000 if it's especially difficult. Insurance usually covers much of the cost.
Sekundiak said annual follow-ups are important. Sometimes devices loosen or fail without causing the patient great pain.
"If you wait till it hurts, usually it's a mess," he said.
Richard Cornelison, a retired letter carrier and school bus driver in Red Oak, Iowa, didn't want to have another hip revision surgery last year. Cornelison, now 78, had a first-time hip replacement in 1995. It became infected and had to be redone that year.
The infection simmered in his system and his surgeon referred him to Sekundiak in 2003.
Evidently the infection stemmed from a case of shingles that Cornelison experienced in 1995. Shingles is a virus, but the rash it caused allowed bacteria to enter his system and migrate to the hip implant, Sekundiak said.
Bacteria love hip and knee implants, the surgeon said, because there's no blood flow there to carry immune-system defenses to fight them. Sekundiak did what he calls a "temporary" redo on Cornelison in 2003, placing antibiotic-coated implants in with the intention of replacing them with permanent material.
The coated implants don't bond well with the bone but help knock out infection.
Cornelison was so pleased with the temporary implant that he squawked at having another redo. "I said, 'I'm not ready,'" Cornelison recalled. "He said, 'Well, I think it's time.'"
And so Sekundiak performed another redo on Cornelison last year. The Iowa man who once played baseball and basketball at a high level and bowled avidly now uses a cane and has a limp. Nevertheless, he still mows lawns, plays cards with his buddies and enjoys his wife of 52 years and their nine grandchildren.
"Been doing fine," he said last week. "I'm not in any pain at all."
Back in Omaha, the Grevings of Central City awaited the surgeon's verdict on their winter trek to Texas.
Sekundiak walked into the exam room. "How you doin'?" he asked.
"Good. I've been exercising every day," Leland Greving said. "I haven't got much faith in hips. I've got a lot of faith in you."
Sekundiak said he understood Greving's decade-long frustration with hips and hip surgery. "The problem is, when they (artificial hip joints) go bad, they don't go a little bad. They go way bad."
He told the Grevings that the bone must grow into the implant, and that will take time. As for the trip to Texas, he said, go ahead.
The couple beamed.
"Well, I really want to thank you," the farmer said.
Sekundiak told him to be true to his follow-up appointments.
"You can never divorce me," Sekundiak said.
"I don't want to," Greving said.
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