A shoulder’s innards seen through an arthroscope looked remarkably like underwater footage of a coral reef. Strands of shredded tissue swayed like kelp in the current of irrigation fluid being flushed through the joint to minimize blood flow. The blood vessels resembled red algae.
But this was not “Blue Planet.” This was the scene on the video screen as orthopedic surgeon Rafael Williams operated on a 72-year-old with a partially torn rotator cuff.
Dr. Williams took about two hours to clean up the shoulder socket, shave a few bone spurs and fix a 30% torn rotator cuff. The repair involved a novel surgical technique using a postage stamp-size patch derived from a cow’s Achilles tendon. Williams is pioneering the bovine implant at St. John’s Medical Center. He learned about the Smith & Nephew product in 2017. Dr. Angus Goetz has also used the patch a few times in open surgeries.
This implant went to Lyle David, who drove with his wife about 150 miles from Pavillion — population 231 — for the operation at the Jackson hospital. It wasn’t David’s first rodeo. Years ago he “wrecked a four wheeler and tore my shoulder up.
“This time I just picked up something too heavy,” David said. “I was getting along pretty good, but I knew I tore it, so I was babying it around.”
By the time we donned our scrubs, tucked our hair into nets and became accustomed to surgical masks over our noses and mouths, he had been prepped for surgery.
David knew Williams from a previous thumb surgery and also had a knee replacement done in Jackson. David typically travels to Jackson or Billings, Montana, for advanced care.
“I like Jackson,” he said.
While Williams might have an idea of how bad a tear is from a pre-op MRI, the use of the patch can be a game-time decision that patients preemptively consent to.
A pricey patch
Four muscles make up the rotator cuff. The top one is the most vulnerable to eroding and fraying on bone spurs, particularly with age. A recent study found that over 460,000 rotator cuff surgeries are performed yearly in the United States.
Options for patients with partial tears previously included ignoring the tear, cleaning it up or completing the tear and then fixing it. Now, this tiny piece of a cow’s Achilles tendon spun down to pure collagen helps the tear heal itself. The implant is held in place with anchors until new tissue grows into it and remodels into tendonlike tissue. The body absorbs the implant within about six months.
“You almost don’t want to believe it,” Williams said.
Originally developed by a company called Rotation Medical with the help of Steven Arnoczky, a sports medicine researcher at Michigan State University, the product won approval from the Food and Drug Administration in 2014. Computer models backed up Arnoczky’s idea that the patch acted as scaffolding, and preclinical studies in sheep worked, too.
The theory is that the patch decreases the load on the cuff to allow the body to heal itself in an area typically under too much tension to do so.
“If you’re fixing a hole in your pants and you did that, but then you laid a patch on top of it, there’s less stress at the hole,” Williams said.
The implant fits a broader industry trend of experimenting with stem cell therapies and methods to trick the body into healing itself.
“We’re really using biology in a lot of different ways,” Williams said. “Biology is really the future of orthopedics.”
In the operating room
During his May 29 procedure David was wheeled into the operating room in an upright, seated position and covered with a surgical drape. Only his left shoulder and arm — marked with permanent marker to ensure no mistakes — were visible during the operation. Before Williams began, he and the team ran through what’s called a “timeout” to make sure everyone was on the same page and no steps were missed.
Music played softly in the background. Williams denied picking the early 2000s hits playlist, including Avril Lavigne’s “I’m With You,” Green Day’s “Wake Me Up When September Ends” and Rihanna’s “SOS.”
Anesthesiologist Dr. Dave Tomlinson came in briefly. But, for the most part, Williams, physician assistant Rosie Boschen, certified scrub tech Lee Kunze and registered nurse Madaline Prather commanded the operation.
Star Valley resident and sales associate Clay Sondgeroth was also there in case his assistance or knowledge of the product was needed.
The team prepared David’s limb with an antiseptic mixture of chlorhexidine gluconate and isopropyl alcohol, a liquid the color of carrot juice that kills microorganisms. Opposite on the color wheel, blue represented all things sterile in the room, including a table full of instruments behind the operating chair.
The arthroscope, or tiny camera, needs light in order to see inside the body. A neon strip of tubing crosses the patient’s body during the procedure to provide it. A reddish glow under the skin shows where the instruments and the camera are.
Shaggy is no good
The shoulder’s ball and socket from the inside popped up on two monitors after the scope was inserted. In a healthy shoulder everything on the scope should appear creamy white and smooth.
But what Williams saw — red fronds — indicated injury. The spot where a full cuff should be resembled a shag carpet.
“It’s like a hangnail on the inside,” Williams said. “It hurts every time he moves.”
Using a heat current that evaporates tissue, Williams quickly cut one of the two bicep tendons, often a source of pain, before proceeding with the task at hand.
Because the other tendon remains, coming from the outside of the shoulder to converge into the single tendon that attaches to the elbow, releasing one doesn’t diminish the elbow’s ability to flex.
At a pre-exam appointment David complained of stiffness. After dealing with the bicep, the team then removed damaged tissue.
Boschen stood on a small stool to be at a better height to help with an ablation, using a tool that resembled an electric toothbrush.
“It’s like singeing the end of a rope with a lighter,” she said. “It cleans up the edges.”
The team continually looked up at screens to guide their movements.
Excess tissue and bone fragments were suctioned out with a system that pumped room-temperature water in and out — a built-in sensor can automatically shut off the water if the temperature grows too hot.
“The technology is amazing,” Williams said.
Both hands — and feet — operated tools during the procedure. Williams’ left foot controlled a bone shaver; his right foot took care of coagulation and vaporization.
Upon closer examination Williams said David had three options. Do nothing and deal with the pain, have the cuff torn fully and repaired, or do this operation. Evidence shows that over half of partial-thickness tears worsen.
“When it looks like crab meat through and through, then it’s really bad,” Williams said of the cuff.
The innovative product being inserted into the patient’s shoulder measures just 26 millimeters and costs roughly $8,000.
“It looks like a postage stamp on a gun,” Williams said.
It is dehydrated presurgery and not refrigerated.
A trigger releases and unrolls the collagen in the shoulder, which rehydrates once it’s in the joint. Blue markings delineate the ends, so surgeons know where the patient’s tissue starts and stops and how the patch overlaps the partial tear. The patch must be unrolled and oriented a certain way to align with the collagen fibers in a manner that maximizes strength.
Scanning the region for landmarks, like blood vessels, helped Williams know exactly where to place the graft. Portals make it easier for various instruments to be used and not go through the skin themselves every single time.
The patch was stapled to the tendon and bone, using sturdier attachment devices for the latter. Williams makes a hammer motion to create little holes for the bone anchors before he can place them.
Once water pressure is gone from the joint, the patch will stick down on the area like plastic wrap.
With the patch in place, cleanup around it continued. Williams compared inflamed small fluid-filled sacs called bursae to “red cotton candy.” The arthroscope clearly showed bone spurs and why they would be uncomfortable, especially when the patient lifted his arm.
“It’s like a sharp rock rubbing on a cloth,” Williams said.
He performed what’s called shoulder decompression to help with that sensation of bone pinching tendon. With that he was done inside the joint.
Reached three weeks after surgery, David said, “So far it’s good.”
“It’s sore,” he said. “But it’s good.”
Between the consultation appointment, surgery and at least one follow-up, David will travel almost 1,000 miles round-trip for care.
Treatment of partial-thickness rotator cuff tears “remains controversial,” according to an article in the Journal of Shoulder and Elbow Surgery. Many techniques can be used, from nonoperative activity modification to purposefully tearing the cuff and repairing it from scratch. Randomized trials haven’t shown one to be superior over another.
After waiting for the patch — now called the “REGENETEN Bioinductive implant” — to develop a record, Williams has used it 50 times for men and women between 40 and 75 years old. After choosing to incorporate the technique in his practice he received additional training at a doctor’s office and a cadaver lab in California.
Doctor likes what he sees
Since his first surgery in the spring of 2018, he’s enthusiastic about how well the product works but assured the News&Guide he isn’t an investor in it or paid to tout its benefits.
“I think the end game is way better,” Williams said.
Surgeons from Alabama to New York are jumping on the bandwagon.
Currently, there’s no definitive clinical evidence to say with certainty that the implant gets patients back to activities more quickly, and any graft has the potential for failure.
Studies, like a 2-year MRI follow-up in the Muscle, Ligaments and Tendons Journal, mostly focus on the finding of new tissue formation that eventually becomes indistinguishable from the tendon underneath. While a 92% patient satisfaction rate was found, the study was relatively small, with only 13 patients.
Another similar study in the same journal, that one with nine patients, found the implant inducing significant tissue formation within three months and stated that this “may represent a significant advancement in the biological augmentation and ultimate durability of rotator cuff repairs.”
Ortho Spine News reported in April 2018 that initial clinical data from 200 patients presented at an Arthroscopy Association of North America meeting in 2017 indicated “that use of the patch resulted in statistically significant improvement in overall shoulder function and pain following surgery. Patch patients generally reported feeling better in the first six months following their procedure than did patients who had undergone more traditional rotator cuff treatments after two years.”
Williams, who fixes about 100 cuffs a year in total, likes what he sees firsthand. Rehab to regain range of motion, strength, power and endurance, he said, appears to be quicker. People seemingly get back to activities faster with less time in a sling. So far Williams has seen no adverse reactions.
“It was really exciting where you could fix something without having to take it apart,” Williams said.
He sometimes uses human tissue grafts in his shoulder surgeries, too, either to bridge large gaps or in salvage procedures.
Different surgeries use other animal parts, like equine pericardium — the membrane that encloses a horse’s heart — and pig intestine as “biological scaffolds” to augment cuff repair. Those are called xenograft tissues. There are also allografts, or decellularized human skin. The augmented repairs are mostly used for wound healing, soft tissue reconstruction and sports medicine.
“If you put in a piece of human skin, it’s always just going to be there,” Williams said. “Your body may grow over it, but it won’t grow into it. So with this, the body kind of absorbs it and grows into it, and it doesn’t stay there as a foreign membrane.”
In a state where cows outnumber humans 2-to-1, it’s easy to assume the farm-to-table movement has made its way to the operating table. But despite the abundance of cattle in Teton County, a local cow’s purified Achilles tendon won’t be making its way into St. John’s shoulder patients any time soon. These cows live on an isolated range in New Zealand.