AAOS’s New Osteoporosis Position Statement
It’s time to take charge of osteoporosis, says a new position statement from the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors. “We are frequently missing the opportunity to prevent a second fragility fracture, says David D. Teuscher, M.D., chair of the AAOS Task Force on Fragility Fractures.
The revised statement, also created by the American Orthopaedic Association (AOA), the Orthopaedic Trauma Association (OTA) and the International Geriatric Fracture Society (IGFS), urges doctors to proactively screen, monitor, and, if necessary, assist in getting treatment for those at risk of osteoporosis following an initial bone fracture.
“We have the assessment tools to predict risk for a second fragility fracture. The fact is that not all of us are making use of them, said Dr. Teuscher, a past president of AAOS, to OTW. If you don’t suspect osteoporosis with a patient who has already had a fracture, you won’t detect it and can’t protect against future fractures.”
“In addition to following ‘best practices’ on osteoporosis and fragility fracture diagnosis and treatment, we are coordinating the development and implementation of data registries that track the care process, as well as patient demographics and outcomes related to fractures. We are also providing more educational materials to orthopaedic surgeons to help them better identify at-risk patients. And we continue to work with the Centers for Medicare and Medicaid Services (CMS) on reimbursement issues as related to the treatment and prevention of future fractures.
“It seems obvious to suspect osteoporosis if you are dealing with an 80 year old lady with a hip fracture. The problem is that it may be a week or two before she is treated and discharged and back in your office. In such cases a DEXA scan [dual-energy x-ray absorptiometry] is a ‘must.’ Aside from the elderly at-risk population, we are seeing a wave of younger people who are developing osteoporosis.
“So when you get a referral for a fracture (either outpatient or inpatient), you should ask, ‘Was the amount of force involved necessary to break the bone consistent with the trauma or should that have been a sprain that got better?’ I always ask patients if they have a primary care physician (PCP), and will write ‘DEXA’ on my referral pad and ask them to bring that to their PCPs to order follow up on the results. I tell them that if the PCP has not ordered it within two weeks then I will do so.
“The next phase is to explore the creation of a registry of fragility fractures so that we can track these into the future. The advantage to patients is that because they are being followed, our knowledge base will better allow us to understand who is at risk, who got what treatment, and what was and was not effective. In addition, we have a professional duty to do what is right for our patients. The Centers for Medicare and Medicaid is very interested in this program, given that surgical treatment of hip fractures is the third most costly musculoskeletal surgical treatment in the country.
“If we could prevent 1, 000 fractures per year we could save a significant amount of money. Part of that prevention effort is ensuring that our patients take the recommended amount of calcium. If, for instance, a patient is post-menopausal, then she should be taking 1500mg elemental calcium each day. Limited sun exposure should also be part of someone’s plan to get enough active vitamin D to help that calcium maintain and strengthen bones.
“Our next step is to secure a business model that enables us to have a clinical registry that would be self sustaining and self-funding into the future. Such an effort would benefit our patients and our profession, and would allow us to earn credit for our maintenance of certification. Ultimately, we are saving patients pain and disability.”
Andrews Institute Tackles Stem Cells
Seven years in the making, a novel stem cell study is almost ready to begin, both in Florida and far away in Kuala Lampur, Malaysia. The goal of the multicenter trial: Improve upon current techniques and outcomes for cartilage repair, as well as harvest more autologous stem cells.
Adam Anz, M.D., an orthopedic surgeon at the Andrews Institute for Orthopaedics and Sports Medicine, in Gulf Breeze, Florida, is leading the research team. He told OTW, “When I was a resident at Wake Forest University, Dr. Khay Yong Saw of the Kuala Lumpur Sports Medicine Center came to our institution and discussed the stem cell and cartilage work he was doing in Malaysia. I became interested, and first visited him in 2009. Since then I have visited six times and spent many weeks there learning his methods of augmenting orthopaedic surgery with mobilized, autologous hematopoetic stem cells. Since then we have been working together to publish data and compile documentation for the FDA so that we can undertake a phase two clinical trial here in the U.S. After completing a fellowship at The Steadman Clinic, I visited for an extended period to complete a mini-fellowship regarding the technology.
“When I arrived at the Andrews Institute, Dr. Andrews told me that stem cells were the next great advancement in sports medicine. In our effort to take these technologies from the bench to patients, in 2012 we petitioned the Gulf Breeze City Council for funds to build a facility specifically for this study. They supported us with a $350, 000 grant, we built the facility, and we then began harvesting and storing this cell type.
“In November 2015 we started testing the facilities capabilities with healthy volunteers— harvesting and processing their cells, and storing them—all to prove that our facility can do this safely. This work was completed in March 2016 and since then we have been packaging the data and plan to begin this trial next spring.”
So what makes their study unique? Dr. Anz notes, “The cartilage world is focused on trying to develop the perfect plug and put it into cartilage defects (scaffold technologies). Dr. Saw’s technology is a paradigm shift as far as how to think about cartilage…it is a shift to optimize wound healing. The goal here is to ensure that there are enough stem cells throughout the wound healing process.
“In the joint environment there is not a large concentration of stem cells, which results in incomplete and suboptimal healing of intra-articular structures such as cartilage. With marrow stimulation techniques (such as the microfracture technique), you make conduits from the bone marrow to the cartilage defect, which stimulates cells from the bone marrow, synovium, and fat pad to home to the area of injury.
“However, there is a limited supply of stem cells in the local bone marrow niche and a limited concentration of stem cells in the synovial fluid. We are trying to augment marrow stimulation techniques and provide more stem cells throughout the healing process after surgery.
“We take large quantities of stem cells at one harvest point-utilizing methods developed for bone marrow transplant, aliquot them into multiple vials, and cryopreserve them so that they can later be removed from the vial and injected into a knee at multiple time points after surgery.
“I use the analogy of a lawn. You prepare the soil, plant the seeds, come back and water/fertilize/reseed the lawn throughout the growing and maturation process.”
As for the FDA process, Dr. Anz commented to OTW, “We are being black and white about the regulations; we are interpreting regulatory statements in a very conservative way because we want to get this right. There are people who said, ‘Well, it looks good. Just go ahead and start treating patients.’ That is not good enough for us. We want stick to the FDA developmental pathway.”
Patient Compliance Issues: Non-Weight-Bearing Restrictions Often Ignored
The admonition to “Stay off that leg” is often ignored by patients after surgery. But now we have work from Brigham and Women’s Faulkner Hospital that puts a number to it.
Researchers embedded pressure-sensitive film into short leg casts of 51 consecutive adult orthopedic patients with unilateral lower-extremity abnormality, all of whom had been instructed to be strictly non-weight-bearing. When the sensors were retrieved at the time of cast removal it turned out that a full 27.5% of patients had not complied with the non-weight-bearing restriction. This, says co-author Christopher Chiodo, M.D., is despite explicit instructions and education about possible complications associated with weight-bearing.
Dr. Chiodo told OTW, “Too often we see post-operative patients who are supposed to be non-weight-bearing yet unfortunately come in with casts that are dirty and worn. In some cases there are even cracks and defects in the heel of the cast. Some patients need extra counseling pre-operatively about the rationale and importance of compliance. They may even need formal training and practice with crutches prior to undergoing surgery.
“I hope that our research will lead to more vigilance and counseling when it comes to compliance and as well more instances in which patients are offered physical therapy pre-operatively so that they are adept with crutches or a walker.
“I remember one patient in particular. He had undergone a fusion and was supposed to be non-weight-bearing. Shortly after surgery he was coming in for a post-operative visit and the staff called me to the office window. From there we could see him walking across the parking lot in his cast while carrying his crutches like a suitcase in one hand.
“I also remember having surgery on my own foot when I was in college. Back then you were admitted to the hospital and post-operatively I had physical therapy for crutch training. Today, with most of our surgeries being performed on an outpatient basis, we lose this opportunity.”
