Orthopedic surgeon Dr. Matthew Brewster had long sought a better treatment option for his younger, still-active patients suffering from arthritic joint pain in their big toe.
The gold standard for moderate to severe big-toe arthritis — a fusion of the bones — could relieve their pain but permanently rob them of mobility in the toe, limiting their ability to partake in athletic activities such as jogging and, for women, wearing heels.
"I didn't like fusing 55-year-old women's toes that want to run and wear heels," said Brewster, who practices at Associated Orthopedists of Detroit and is affiliated with Beaumont Hospital in Grosse Pointe.
So when the U.S. Food and Drug Administration last July approved the first synthetic cartilage-like implant as a treatment for big-toe arthritis, he signed up. Brewster performed his first procedure with the Cartiva implant that month, helping a 62-year-old Clinton Township woman regain the ability to wear shoes without pain and even go running.
She became only the second U.S. patient to receive the implant, which has been available in Europe for more than a decade. The first procedure was in Rochester, N.Y.
Brewster, the procedure's second U.S. doctor, has since successfully treated 13 patients with the implant. All of them were relieved of their pain and kept about half of their pre-arthritis joint mobility, he said.
Although the implant material is only currently approved in the U.S. for the big toe, it has been successfully used to treat arthritic thumbs and knees in Canada and Europe and offers hope for the millions of arthritis sufferers who wish to remain active and avoid joint replacements that steal their mobility and require extensive surgeries once the devices wear out.
An estimated 2.7 million middle-age people in the country right now have big-toe arthritis.
Brewster's patients' health insurance agreed to cover the Cartiva implant and procedure costs, which are said to be slightly higher than a standard bone fusion.
"When he approached me with this, it sounded too good to be true — it's not," said Karen Schumann, 51 of Chesterfield Township, Brewster's most recent patient, whose big-toe procedure was Feb. 22.
In an interview last week, Schumann recalled how her left toe had been in increasing pain for nearly 10 years and that she could no longer bend it. Now more than three weeks after the operation, her pain level is "zero," and she once again can go on long walks for exercise and go up and down stairs.
She hopes to have the same procedure done later this year on her right foot.
"I am so glad I had it done. You never realize how much you use the big toe until it hurts," Schumann said.
Headquartered outside Atlanta with 25 employees, Cartiva developed its Synthetic Cartilage Implant through research that originated out of Georgia Tech. The device is made of polyvinyl alcohol hydrogel, the same material as contact lenses, but is much thicker and the result of a patented process that makes the material incredibly tough yet with a water content comparable to healthy cartilage. Each implant is expected to last many years, although the material is still too new to make precise estimates.
Cartilage is a smooth, connective tissue that has a limited ability to repair itself if damaged. Researchers have been trying for decades to find a way to replace it. Degenerative arthritis occurs when cartilage gets worn away and bones then rub against each other.
"Synthetic cartilage or injectable cartilage or some type of implantable cartilage is definitely the Holy Grail of orthopedics," said Dr. Todd Irwin, a foot and ankle orthopedic surgeon at the University of Michigan Health System who has done two Cartiva implant procedures.
"I think this is very promising," Irwin said, but added, "I think calling it synthetic cartilage is personally a little bit of a stretch. To me, functionally it's more of a bumper" between the bones.
Cartiva first introduced its hydrogel implant in Europe in 2002. But gaining FDA approval entailed more clinical trials and didn't happen until last July.
How it works
Big-toe arthritis, known as hallux rigidus, is the most common arthritic condition in the foot and said to affect 1 in 40 people older than 50, or roughly 2.7 million people in the U.S. Doctors say the problem can arise from genetics, past injuries or repeated stress from work occupations such as flooring installation.
Yet only about 100,000 Americans each year — the majority of them female — get surgical treatment for the condition, through fusions or typically metal joint implants. Those with less severe arthritis can find relief through a cheilectomy, which involves cleaning out the joint and removing bone spurs, although that procedure currently rules out getting a Cartiva implant later on.
Doctors say the biggest problems with traditional implants for the big toe are the relatively high complication rates and how they often don't last beyond seven years.
The Cartiva cartilage works like a bumper over the joints and is inserted into the base of the big-toe through a drilled hole.
Brewster said the procedure is relatively simple and takes him about 25 minutes. He considers it easier to perform than a traditional joint fusion of the toe, which takes more than an hour and involves scraping out cartilage, packing in a cadaver bone graft, then screwing two bones together with a metal plate.
Patients are sedated during the procedure and afterward can actually walk out of the clinic. For two weeks they are asked to wear a post-operative shoe, like a hard sandal. After that they can return to regular activities.
A small peer-reviewed study of 27 Cartiva patients in Canada and the United Kingdom found that five years after the implant, toe functionality had improved significantly in nearly everyone compared to before their procedure, the pain was significantly reduced and the synthetic cartilage was in good shape.
A full 96% of the patients said they would undergo the procedure again.
Rosalynn Demers, 62, of Clinton Township was the first Michigan patient to receive the Cartiva implant. She had been enduring progressively worse big-toe pain for about a year and could no longer wear most shoes because of pain.
"I thought it was a bunion, but it was arthritis. It was a gradual thing and then (the pain) just became ridiculous," she said. "I thought I as going to give all my shoes away, thinking that I'd never fit into them again."
She had planned to get a fusion, even though she knew the procedure would bring an end to her running hobby. Then she learned about the new FDA-approved synthetic cartilage option from her husband, Dr. Mike Demers, an orthopedic surgeon who is a colleague of Brewster's.
In late July, Demers became the second person in the country to get the procedure. It was a success. Not only is she back to wearing almost all of her shoes, but she returned to running and even raced in the Detroit Turkey Trot 5K in November.
"I couldn't believe I ran the whole thing," she said. "It wasn't fast, but I ran it. So I thought that was pretty incredible."
Schumann, the Chesterfield Township woman who just had the procedure, recalled how Brewster demonstrated the new pain-free range of motion in her toe during a check-up appointment. Prior to the operation, a sudden movement like that would have caused searing pain.
"All of the sudden, he bends my toe all the way down and I'm like, 'What!'" Schumann said. "He says, 'Does that hurt?' and I go, 'No you just scared me.' My toe has not been bent like that in years."
What it costs
The list price of each Cartiva implant is $4,500, although hospitals can get a discount from the company.
A Beaumont representative said the Grosse Pointe hospital's total charges for the Cartiva procedure average $15,000 to $17,000. Insurance companies then typically pay around 33% of the charges, or about $5,000, leaving the hospital to write off the remaining balance. Those charges do not include the surgeon’s fee, which is billed separately to insurance.
Nationwide, the average big toe-fusion is billed at $10,000 to $11,000 before insurance — not including the surgeon's bill, according to James Laskaris, an emerging technologies senior analyst at MD Buyline, a Dallas-based firm that provides clinical and financial information to hospitals. The surgeon is typically a $3,000 to $4,000 separate charge, Laskaris said.
In addition to big toes, doctors in Europe and Canada have had success using Cartiva implants to treat arthritic thumbs and knees.
Dr. Philip Sauve in the U.K. said he has treated 12 patients with thumb arthritis with a Cartiva implant. All had good results, he said.
"The pain is reducing, their grip strength is increasing and so their function is improving," Sauve said in a phone interview. "So for that group who maybe is still working and still very active, I think it's a really good option."
Contact JC Reindl: 313-222-6631 or firstname.lastname@example.org. Follow him on Twitter @JCReindl.