Blunt Observations From the AAOS Exhibit Hall

Caution: This article has forthrightness and candor. It should only be read by seated and calm readers.

The recent annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans brought surgeons back to device company booths to talk about new technologies which, in turn, led to papers and science and…a fair amount of BS.

TED speaker and one of the most innovative and knowledgeable sports medicine physicians in the world, Kevin Stone, M.D., of the Stone Clinic in San Francisco, graciously agreed to give OTW his honest and candid observations of the products, papers and new technologies that filled the exhibit halls and were presented from podiums at AAOS’s annual meeting.

Dr. Stone is one of the most demanding physicians we know and he really cast a discerning eye on the products, research and companies he encountered at AAOS.

His comments are interesting and insightful. And straight to the point. – Walter Eisner, Senior Writer

Biologics: Science Ahead of Performance

One thing that Dr. Stone noticed right away was the tremendous interest among the companies in biologic products and instruments that can put biologic treatments into the hands of physicians (scaffolds, PRP, bone marrow harvests for stem cells). But, he noticed, most major orthopedic suppliers have overlapping offerings. And, furthermore, the papers which these firms trotted out were, frankly, weak.

“Unfortunately while the intuitive understanding of biology says these should work, the papers presented demonstrated that the science is far ahead of the clinical performance. PRP (platelet-rich plasma) in particular seems to be a mixed bag of multiple growth factors with no consistency either between the products or even from the same patient at different times of the day. With this dramatic difference from what the regulatory bodies are used to seeing, one only wonders how the field will remain wide open and how the payers will deal with this variability in treatments and outcomes.”

He noted a genuine concern in a number of papers on the role of hyaluronic acid (HA), with some organizations now refusing to reimburse for it while others claim it has dramatically delayed the time for joint arthroplasty for many patients. “The role of joint lubrication in cartilage repair versus arthritis is yet to be defined although the science suggests that HA is very beneficial to healing cartilage.”

Shoulders: Cuff Repair Stuck in the Past Century

Stone noted that there appeared to be considerable overlap in topics at the Specialty Day meetings of AANA (Arthroscopy Association of North America) and AAOS. He said the hot topic is whether or not the extensive rotator cuff repair techniques using multiple anchors and sutures is any better than a more cost effective single anchor approach. “The success of cuff repair remains a disturbingly low number with possibly as many as 40% re-tears. The rehabilitation of rotator cuff repairs remains in the 20th Century with many top surgeons afraid to let their patients have active motion or strengthening for months after repair. This is reminiscent of the old days of ACL surgery.”

“SLAP [superior labrum, anterior to posterior] lesions of the shoulder are now being referred to as the plica of the shoulder with many papers demonstrating that very few (5%) of all SLAP tears need any surgical treatment. This is dramatically different from a few years ago when all the rage was new techniques in SLAP repair.”

The biceps tendon, added Stone, remains similar to the meniscus of the knee. “When diseased, the only treatment is destruction of the tendon by removal or anchoring non-anatomically. It is odd that there is almost no science around repairing this structure which so obviously plays a key role in the shoulder.”

The Knee and Meniscus Replacement: A House Divided

For knees, Stone said meniscus replacement remains quite divisive.

Papers at the Meniscus Transplant Study Group focused on the importance of repairing the meniscus skirt ligaments in order to restore normal anatomy. He said there were multiple comments on expanding the indications for meniscus replacement, since it appears to provide long-term pain relief and improved function even in arthritic knees. He noted a paper by the Rush group demonstrated significant success in a series of 200 patients, though there was a high reoperation rate for scar tissue and other issues.

“A dramatic paper presented at the AAOS confirmed earlier data from Stone et al. that there was no difference in patients who received a meniscus transplant plus an osteotomy versus those who received the transplant alone. Alignment did not affect outcomes. This contrarian data disturbed many of the osteotomy surgeons particularly in Europe but is supported by other studies as well. The contrary argument was presented at the AANA meeting in a panel where the surgeons repeated the dogma that meniscus transplantation was only for the young and healthy knees without mal alignment. The techniques presented were old time open surgery despite the fact that all arthroscopic meniscus transplant techniques have been well published. It is unclear why the anti-meniscus transplantation bias still exists but the contrast is stark in the opinions and data.”

Stone said data on long-term successful outcomes of CMI [collagen meniscus implant] implantation from Europe continues to be reported, particularly by the Rizzoli group. “Zero complications in over 24 years of clinical use now should convince the FDA that revoking the approval for a device that helps so many people without a downside was a dumb idea. But don’t hold your breath. The CMI may come back as a PRP delivery device to augment meniscus repairs.”

Put a Nail in the Double Bundle Coffin

Finally, Stone said the double bundle era is coming to a close for many surgeons. “Hyped by the companies that sold many more fixation products and by one of the university groups, the data is simply not convincing enough surgeons that two holes are better than one for anatomic ACL surgery.” The best contribution from that era, said Stone, was to alert many surgeons of the importance of putting the ACL into the anatomic footprint.

The End of Hardware

The take away for general orthopedic surgeons and companies, said Stone, is that orthopedics is entering the anabolic era and leaving the age of cortisone and hardware as primary treatments.

“We have come to understand that it is better to stimulate repair by adding growth factors, cells, tissue, and scaffolds to injured areas rather than remove the tissue (meniscus, biceps tendon, damaged cartilage, hip labrum) even if the outcome is not perfect. ‘Better is better than artificially replaced, ’ is the mantra of the biologic surgeon. Patients are becoming aware that cortisone represents inhibition of healing and that metal and plastic represent the last resort. The reports that up to 50% of patients with total knee replacements still have pain are circulating amongst the golfing crowd.

Safety First, Effectiveness Post-Market

He says that if the FDA approval process is to modernize and understand the gradations of improvement then shifting to safety approvals first with crowd sourced outcome data to follow new products is the way forward. Translated, he says this means, let new products on the market after safety studies and let the efficacy be determined by total post market release data. While not acceptable in the past, the Internet has provided the tools for far more clear data.

Big Data and Reimbursement

“Most patients have cell phones, email and are registered in some type of electronic record. The increased use of EMRs makes data collection even easier with integrated outcomes tools. For those not using EMRs, several companies have started to provide tools to organize and streamline the collection of outcome data. For surgeons, there is no longer any excuse to not follow all patients with at least subjective outcome measures filled out electronically. Look for these big data sets as a requirement for approval in the not too distant future.

So if it is better to stimulate repair first, which products to use? Is a partially repaired or restored joint with modest improvement better than a removed joint? Outcome data will decide the answer to these questions. For surgeons and companies alike, outcome data will rule the reimbursement world.