Can regenerative orthobiologics heal your injury faster, too?
Seventeen years old, with long blond hair and powerful athletic confidence, Leah Strachan is a star cheerleader at Sacred Heart High School in Waterbury. She jumps, spins and tumbles through football games like a competitive gymnast. She trains in private lessons and cheerleading camps, and holds an all-American title. “Honestly, it’s exhilarating,” she says, talking about her moves. “It’s like flying. It’s like you’re defying gravity.”
But in November 2015, Strachan’s career hit an abrupt halt. She landed on the mat at practice one afternoon to crushing pain in her left ankle. An X-ray didn’t reveal any fractures, but walking quickly became painful and her ankle swelled. Strachan saw several doctors before she met Raymond Walls, MD, a Yale Medicine orthopaedics and rehabilitation surgeon, who started by exhausting the nonsurgical solutions, including bracing and physical therapy.
Finally, Dr. Walls proposed a complex surgery to rebuild Strachan’s ankle, augmented by an orthobiologic treatment that would use her own stem cells as an agent to help her heal faster and, hopefully, better than the surgery alone could do.
Dr. Walls was confident that if the orthobiologic augmentation worked, Strachan would return to the same level of performance as before her injury. He said that there was a chance—perhaps 15 percent—that it would not work. He made it clear that the treatment was considered somewhat experimental, and there was not, as yet, solid clinical research supporting its efficacy.
However, a wealth of preclinical evidence was showing very impressive results from other patients who’d had the orthobiologic treatment. “Patients have often asked about growing new cartilage,” says Dr. Walls. “But, while such techniques do exist, they are very expensive and the outcomes are mixed.” He believes this new method of cartilage repair with orthobiologic augmentation will be a game changer in patients just like Strachan.
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A way to stimulate healing
Over the past decade or so, many professional athletes—from NFL players to pro golfer Tiger Woods—have had orthobiologic treatments. (You may have heard it described as regenerative medicine—or sometimes regenerative injection medicine. The terms are interchangeable and all describe the same procedures.) There are different kinds of orthobiologic treatments. All of them use natural substances found in the body to help injuries heal faster and typically with a better quality of tissue repair.
While Strachan’s proposed treatment was part of an operation, other orthobiologic treatments can be performed in an hour in a doctor’s office. They may involve a simple blood draw and injection, and they have helped people delay surgery or avoid it altogether.
The orthobiologic treatments Yale Medicine doctors are using successfully to enhance healing include:
Platelet-rich plasma (PRP): This can be administered in the doctor’s office under local anesthetic. It takes less than an hour from start to finish, says Vivian Shih, MD, a physical medicine and rehabilitation (PM&R) physician, and one of several Yale Medicine specialists who provide this treatment. A blood sample obtained from the patient’s arm is spun in a centrifuge to separate out highly concentrated, protein-rich platelets, which contain growth factors that are essential for healing. Once that work is complete, the doctor will use ultrasound guidance to inject the PRP substance into the site of the injury, be it a tendon, ligament or joint.
Bone marrow aspirate concentrate (BMAC): This is the treatment Dr. Walls recommended to Strachan. In the operating room, often as part of the same surgical procedure, the doctor draws bone marrow from the patient’s pelvis. The marrow is put in a centrifuge and spun down to obtain a high concentration of mesenchymal stem cells and growth factors. These are cells that have the ability to turn into the necessary repair cells in the specific body area into which they are injected. “It’s a bit like adding nitro to a car engine,” as Dr. Walls describes it. “We use the patient’s own reparative body cells in a high concentration to greatly enhance the natural healing process.”
Human amniotic fluid : David Kovacevic, MD, a Yale Medicine orthopaedic surgeon specializing in shoulder and elbow problems, uses this product to treat patients with rotator cuff injuries, mild shoulder arthritis and labral tears. He provides the treatment, which is sourced from human placental tissue, by injection with ultrasound guidance, in an exam room.
The approach to using all of these products is still evolving. “There is a world of research going on behind the scenes,” says Dr. Kovacevic.
Dr. Kovacevic has been very involved in this research and currently has a foundational grant from the American Shoulder and Elbow Surgeons. He is studying the use of human amniotic fluid, which he says has been used as a treatment since the 1940s, in rotator cuff injury and repair. Based on promising preclinical results, he has started to use the product to treat select patients with rotator cuff injury and mild shoulder arthritis. He also provides PRP for patients with soft tissue injury in their elbow.
“Two of my patients, one who is an avid weightlifter and the other a CrossFit athlete, were able to return to those activities after a human amniotic fluid injection for their shoulder arthritis,” Dr. Kovacevic says.
Dr. Shih, who provides nonsurgical care for patients at the Center for Musculoskeletal Care in Stamford, a partnership between Yale Medicine and Greenwich Hospital, has given PRP to select patients who do not respond to other nonsurgical treatments. She has seen the treatment provide pain relief and return of function for people with tendinopathies, partial tendon tears and osteoarthritis.
Augmenting a highly complex treatment
Strachan and her family weren’t concerned about trying a treatment that doesn’t come with a full guarantee. “I think for Leah and for us, the decision was really about giving her a chance to see her dreams come true,” says Christina Strachan, a trauma nurse, who became the family member to ask the most questions about her daughter’s injury.
Athletics were in Leah Strachan’s family—her grandfather had been a local football coach and her grandmother was a cheerleading coach.
The last thing Leah Strachan wanted was to see her athletic career suddenly end, but her ankle only got worse, and she developed a deep clicking sensation along with ankle instability. She could no longer complete even the most basic training session without debilitating pain.
Dr. Walls diagnosed the key injuries as a combination of an ankle osteochondral lesion (damage to the joint surface) and an ankle ligament rupture. To make things worse, the injury had caused chronic inflammation and buildup of scar tissue inside the ankle. If that wasn’t enough, a small fragment had chipped off of the ankle bone and was stuck inside Strachan’s ankle.
The surgery would be a complex one. First, Dr. Walls used a minimally invasive procedure known as keyhole surgery (or ankle arthroscopy) to carefully remove the inflamed and thickened scar tissue. He then worked through the scope to assess the damaged joint surface, which by this point was in terrible shape—he likened it to a severely damaged portion of a rubber tire covering a car wheel.
Once he removed the damaged area of ankle cartilage surface arthroscopically, Dr. Walls made small holes in the underlying bone surface to stimulate bleeding to fill the defect in the cartilage. This procedure has been the standard treatment for osteochondral lesions for many years, but it is not considered a permanent fix because the tissue often starts to fail after five years. “What fills the hole is essentially a form of cartilage scar tissue; it works well for a time before it starts to spontaneously fail,” says Dr Walls.
The addition of the BAMC called for advanced, pioneering skills on Dr. Walls’ part. While Strachan was still under anesthesia, he extracted bone marrow from her pelvic bone, and spun it in a medical centrifuge to obtain a high concentration of stem cells and growth factors. “We took the technique a step further by combining the stem cells with a cartilage scaffold (to hold the stem cells within the cartilage defect),” Dr. Walls says. Preclinical studies have shown that this technique can further enhance the formation of normal cartilage after injury. “We believe this will extend the lifespan of the repair tissue way beyond five years and hopefully last a lifetime,” he says.
Finally, Dr. Walls fixed the ligaments that had partially detached from Strachan’s ankle bone and removed the loose bone fragment that was adding to her painful motion.
Getting back on the field
Strachan turned out to be one of Dr. Walls’ many success stories. She wore a splint for two weeks after her surgery, then transitioned to a walker boot and started intensive physical therapy. Even though she was not allowed to practice yet, she put on her cheerleading uniform and went to practices on crutches and sat on the sidelines.
In the early stages of rehabilitation, Dr. Walls was unbending in his instructions not to rush. “I didn’t expect a quick turnaround. She actually had to regrow new cartilage,” says Christina Strachan.
At six weeks after the surgery, Strachan’s ankle was stable, her pain was gone and her range of motion was almost normal. She started physical therapy and progressive weight-bearing. By three months, she was doing sports-specific rehabilitation, starting with low-impact exercises. At six months, she was doing gymnastics again.
“That is an incredible result,” Dr. Walls says. While there is no way to be sure how much the BMAC helped, follow-up MRI studies showed high-quality cartilage forming in the area of Strachan’s injury.
If you’re considering orthobiologic treatment
But the risks and benefits that seemed clear to Strachan’s family can be confusing for other people, whether they are considering treatment with BMAC, PRP or amniotic fluid. One good thing about BMAC and PRP is that they eliminate such concerns as getting an infection from a donor, or rejecting the treatment, as can happen when a donor substance is used.
One downside of orthobiologics is that they are usually an out-of-pocket expense, partly because insurance companies want to see more research on their efficacy, Dr. Walls says. So do doctors. Treatment protocols aren’t yet standardized, so the many independent providers offering orthobiologics are not all consistent in their approach, he says. This makes it difficult to build up a database of information on how these treatments are working for patients, he adds. “There is a risk that patients may be treated for conditions using orthobiologics where there is not a formal indication—or without a full understanding of what the anticipated result may be.”
But Dr. Walls and his colleagues are nonetheless enthusiastic about the potential of the treatments. “The data that is starting to come out from international meetings is very positive,” he says. He notes that researchers are looking for answers to many questions. They are still trying to determine, for instance, which PRP solutions work best for which injuries. Researchers know some platelet solutions have different anti-inflammatory effects that may work better for knee arthritis, while others may be more likely to help Achilles tendinitis. The quantity of the white blood cells (or leucocytes) appears to be a factor that can affect outcomes. “Such an effect could help explain the variation in positive outcomes from early studies,” Dr. Walls says.
For these reasons, Yale Medicine doctors encourage patients to seek orthobiologic care at academic medical centers, where they can feel confident that their physician is on the forefront of research. “We have protocols for these procedures and are selective in using them in an appropriate manner,” says Dr. Shih.
For Leah Strachan, BMAC was the right choice, says her mother. This past summer, her daughter was learning a challenging new tumble and planning for a first senior year semester that would include good grades, cheerleading and writing applications to colleges where she could be part of a cheerleading squad.
“I think Leah is tumbling again because of that treatment,” Christina Strachan says. “We’re at a year and a half now, and she is fully back.”