Nearly two years ago, Sean McMillan, DO, chief of orthopedics and director of orthopedic sports medicine at Virtua Medical Center in Burlington, N.J., debuted the BEAR implant, an alternative to traditional ACL surgery that allows the body to heal on its own, at the facility.
Since then, he has helped many patients, including professional athletes such as mixed martial arts fighter Ryan Cafaro, return to their daily lives with less pain.
Dr. McMillan operated on Mr. Cafaro in April 2022 as part of a clinical trial for BEAR.
"Last year I was googling 'pro bono ACL surgery,' and what pops up is the clinical trial for the BEAR ACL implant," Mr. Cafaro told Becker's. I did a lot of research and read a lot of study results about how they tried it on pigs and how their ligaments were showing a reduction in arthritis over the long haul. That all made sense to me and I thought, being that the surgery has less invasiveness and less aggressiveness, I assumed I would heal faster."
Mr. Cafaro was right. By following his physical therapy regimen and maintaining a healthy diet, he was able to return to MMA fighting and running several miles a day with little to no pain or arthritis in his ACL.
"I've always been a big believer in biologics for orthopedics," Dr. McMillan told Becker's. "Long before there were surgeons, the body had the ability to heal itself. Back in the 1700s, we just broke bones and they healed. I did some work in medical school looking at biologics to heal ligaments and tendons. Now, 20 years later, that technology is the foundation, in part, for what we're seeing now with a lot of the new biologic agents for rotator cuffs and ACLs."
"It inherently made sense that we could get the body to heal if we figured out the right sort of algorithm for dealing with it. The ACL is the only ligament in the entire body that we never sewed back together. Everything else that you tear, we sew back together. We don't replace it. As we started learning about it and doing our homework and research on it, a lot of the science made sense, and I had a patient population that was young and active and that would benefit from BEAR."
With other ACL repair surgeries, including patellar tendon replacement, hamstring tendon replacement and cadaver ligament replacement, patients report high levels of failure, rejection rates and increased arthritis pain over time, Dr. McMillan said.
"If you tear your ACL when you're 18, you're going to love me for the first couple of years, but then people come back 10 years later with knee pain, arthritis, things that affect you when you want to have a family and when you're done playing high school and college sports," he said.
In animal trials, the BEAR ACL repair has shown less arthritis and reinjury risk over time by 30 percent to 40 percent.
"Other repair techniques out there for the ACL aren't biological, so we're waiting to see if others can work as effectively long term like the BEAR can. There's a growing interest among surgeons and patients to save your normal ACL, and that's where it's headed," Dr. McMillan said. "We're hearing that the knee feels more natural. I've had a couple of patients now that have had a traditional bone tendon on one knee and then came for a BEAR on the other knee. They say the BEAR knee feels like it's their own.
"God didn't give you a patella tendon for an ACL originally — he gave you an ACL for a purpose. BEAR lets you keep the natural fibers between the shin bone and the femur bone so the knee always knows where it is and walks more naturally. That's able to be restored by keeping your own ligament. When we reconstruct it and give you a new ACL, those fibers go away. That's why we're seeing less arthritis in patients with BEAR as they age."
The risk of reinjury with the BEAR implant is also proving to be lower. For athletes such as Mr. Cafaro, that is another draw to the surgery.
"I have not torn my ACL since the procedure, and it doesn't seem like it will tear anytime soon," he said. "If you want to talk about testing this thing, I was in a rough fight a month ago. It was really back and forth. I was kicking with the leg, getting kicked in the leg, it was as rough a physical test as you could get. I've never gotten a regular ACL reconstruction, but I wouldn't be surprised if that had re-torn it. I've seen a lot of professional athletes who lose their knee immediately when back in a competitive situation."
While the BEAR implant is gaining popularity nationwide, there are still barriers to its implementation, including patient education, pricing and insurance battles.
"It will be a slow adoption," Dr. McMillan said. "Limitations like pricing and insurance will work themselves out as payers see benefits and see that patients need and want it. As use goes up, price comes down. It's going to be used a lot more widely. The biggest barrier is simply education and price point. That's something surgeons can't control fully."
"There's a lot of education that goes on. Appointments that used to take 15 minutes took 40 minutes because I wanted to get as much information off my chest to the patient and patients had a lot of questions. Now that it's becoming more mainstream, there are a ton of chat boards for patients and they can get information before they even walk in the room. My patient population, in the past almost two years we've been doing this, their education level is through the roof, whereas in the beginning I was talking to them about how I could do this brand-new procedure no one had heard of."
While outcomes for the procedure have been positive overall, both Mr. Cafaro and Dr. McMillan caution patients that the recovery is not easy.
"Once I'm done with the surgery, my part is done. You have to bust your hump to get better," Dr. McMillan said. "The return to sports is rarely predicated upon time; it's about getting the strength and the knee in a position to succeed. I might say you can't do something for nine months because we know that's how long the healing process is. After that, if you're ready to go, I'll let you go. But it's all about you at that point."
"My experience was that I got out of the surgery what I put into it. I put in a lot of work to make sure I got the most of it, and I could not be happier," Mr. Cafaro said. "It worked well for me, but also my confidence in the BEAR surgery probably had a result as to why I healed so well. I trusted it from the start.
"My surgeons might have said, 'Hey you might recover a little bit faster doing a traditional ACL repair,' but if I had to wait an extra two months so I could have no arthritis in my knee 10 years from now, it's worth it for me. For me, this was a no-brainer based on the research and the data showing long-term performance, not just the foreseeable year or so."