Fracture liaison services and similar coordinated, multidisciplinary fragility-fracture reduction programs for patients with osteoporosis work (see related OrthoBuzz posts), but until now, the data corroborating that have come from either academic medical centers or large integrated health care systems. The November 7, 2018 issue of The Journal of Bone and Joint Surgery presents solid evidence from a retrospective cohort study that a private orthopaedic practice-based osteoporosis management service (OP MS) also successfully reduces the risk of subsequent fragility fractures in older patients who have already sustained one.
Sietsema et al. collected fee-for-service Medicare data for Michigan residents who had any fracture from April 1, 2010 to September 30, 2014 (mean age of 75 years). From that data, they compared outcomes for patients who received nurse-practitioner-led OP MS care from a single-specialty private orthopaedic practice within 90 days of the first fracture to outcomes among a propensity-score-matched cohort of similar patients who did not receive OP MS care. There were >1,300 patients in each cohort, and both groups were followed for an average of 2 years. The private practice’s OP MS services incorporated the multidisciplinary protocols promulgated by the American Orthopaedic Association’s “Own the Bone” program.
The cohort exposed to OP MS had a longer median time to subsequent fracture (998 versus 743 days), a lower incidence rate of any subsequent fracture (300 versus 381 fractures per 1,000 person-years), and higher incidence rates of osteoporosis medication prescriptions filled (159 versus 90 per 1,000 person-years). Over the first 12 months of the follow-up period, total medical costs did not differ significantly between the 2 cohorts.
These findings are consistent with those reported from academic or integrated health-system settings. According to the authors, this preponderance of evidence “emphasize[s] the importance of coordinated care in reducing subsequent fractures, lengthening the time to their occurrence, and improving patient outcomes.” Sietsema et al. conclude further that “the U.S. Medicare population would benefit from widespread implementation of such models in collaboration with orthopaedic providers and payers.”
On Thursday evening, June 28 and all day Friday, June 29 in Boston, The American Orthopaedic Association (AOA) and the National Association of Orthopaedic Nurses (NAON) will present two educational/networking events concentrating on secondary fragility fracture prevention.
The Thursday evening Workshop, available only to those attending the Friday Symposium, will convene clinicians with expertise in counseling and treating fragility fracture patients. “This new two-hour workshop provides an additional opportunity to learn more about identifying, assessing, counseling, and treating fragility fracture patients,” said program co-chair Debra Sietsema, PhD, RN. “The Workshop also includes special breakout stations on calcium, FRAX, and the AOA’s ‘Own the Bone’ initiative.”
The all-day Symposium on Friday focuses on how to establish a multidisciplinary secondary fragility fracture program. In addition, the Symposium will include relevant case studies demonstrating how to translate the principles into hospital, private-practice, or clinic settings. “This Symposium is a great opportunity for orthopaedic surgeons and allied health professionals to get the full picture in one day,” said Dr. Sietsema. “Attendees will gain both basic and expanded knowledge to put their programs in place.”
Register by May 15 to receive early-bird pricing for these important events. NAON members and clinicians from enrolled Own the Bone institutions save an additional $50.
How well do fracture liaison services (FLSs) work in terms of patients who’ve had a fragility fracture receiving a recommendation for anti-osteoporosis treatment? Very well, according to findings from an analysis of more than 32,000 patients by Dirschl and Rustom in the April 18, 2018 edition of The Journal of Bone & Joint Surgery.
A fracture liaison service is a coordinated, multidisciplinary model of care designed to reduce the risk of future fractures among patients who’ve sustained a primary fragility fracture. (Click here for another recent JBJS article about the FLS model.) The American Orthopaedic Association (AOA) has been a major proponent of the FLS model, and it is a cornerstone of the AOA’s “Own the Bone” national quality-improvement program.
Dirschl and Rustom found that between 2009 and 2016, at 147 sites participating in an FLS through Own the Bone, 72.8% of 32,671 patients initially evaluated for a fragility fracture received a recommendation for anti-osteoporosis treatment. That’s a vast improvement compared with previous reports that indicate only 20% of patients with a fragility fracture received either an osteoporosis evaluation or treatment. In this current study, a sedentary lifestyle and having a parent who had sustained a hip fracture were the patient factors associated with those most likely to receive a recommendation for treatment.
OrthoBuzz editors were surprised to read that anti-osteoporosis treatment was initiated in only 12.1% of the patients in this study. When we asked JBJS Editor-in-Chief Marc Swiontkowski, MD for a further explanation, he noted that the study captured data only from the initial post-fracture encounter between patients and FLS clinicians. The percentage of patients initiating treatment would have been much higher, he said, if the data had included those who followed up their initial FLS evaluation with a primary care physician. He also remarked that some people are dissuaded from taking an FDA-approved prescription anti-osteoporosis medication by the disproportionate focus on side effects that patients read in social media and the lay press. And there are some patients for whom prescription anti-osteoporosis drugs are truly contraindicated.
But with an estimated 2 million people in the US sustaining a fragility fracture each year, these results indicate substantial progress in practices that will prevent secondary fractures.
Click here for a listing of upcoming Own the Bone events.
This basic science tip comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.
Bone mineral density (BMD)—a measure of both cortical and trabecular bone—has been widely used as an index of bone fragility. The femoral neck and lumbar vertebrae are the areas most commonly measured with BMD, but hip osteoarthritis and lumbar spondylosis can mask systemic osteoporosis. In addition, the most common fragility fractures occur at the distal radius.
Investigators conducted a prospective study using high-resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius and tibia to determine whether baseline skeletal parameters could predict fragility fractures in women. A second goal was to establish whether women who have fragility fractures experience bone loss at a faster rate than those who do not have fractures.
Among 149 women older than 60 years who had baseline and 5-year follow-up HR-pQCT, 22 had a fragility fracture during the study period and 127 did not. HR-pQCT is able to record total bone mineral density (Tt.BMD), trabecular bone mineral density (Tb.BMD), trabecular number (Tb.N), and trabecular separation (Tb.Sp).
The analysis showed that women with fragility fractures had lower baseline Tt.BMD (19%), Tb.BMD (25%), and Tb.N (14%), along with higher Tb.Sp (19%) than women who did not experience a fracture. Analysis of the tibia measures yielded similar results, showing that women with incident fracture had lower Tt.BMD (15%), Tb.BMD (12%), cortical thickness (14%), and cortical area (12%). Also, women with fractures had lower failure load (10%) with higher total area and trabecular area than women without fractures.
For each standard deviation decrease of a measure at the distal radius, the odds ratio for fragility fracture was 2.1 for Tt.BMD. 2.0 for Tb.BMD, and 1.7 for Tb.N. ORs for those measures at the tibia were similar.
In contrast to these findings, the annualized percent rate of bone loss was not different between groups with and without fractures. These results suggest that future fragility-fracture risk prediction should rely at least as much on bone architecture and strength as on simple BMD measurements.
Burt LA, Manske SL, Hanley DA, Boyd SK. Lower Bone Density, Impaired Microarchitecture, and Strength Predict Future Fragility Fracture in Postmenopausal Women: 5-Year Follow-up of the Calgary CaMos Cohort. J Bone Miner Res. 2018 Jan 24. doi: 10.1002/jbmr.3347 PMID: 29363165
In the past several years, the orthopaedic community has become highly engaged in improving the follow-up management of patients presenting with fragility fractures. We have realized that orthopaedic surgeons are central to the ongoing health and welfare of these patients and that the episode of care surrounding a fragility fracture represents a unique opportunity to get patients’ attention. Using programs such as the AOA’s “Own the Bone” registry, increasing numbers of orthopaedic practices and care centers are leading efforts to deliver evidenced-based care to fragility-fracture patients.
In the November 16, 2016 edition of The Journal, Aspenberg et al. carefully examine the impact of the anabolic agent teriparatide versus the bisphosphonate risedronate on the 26-week outcomes of more than 170 randomized patients (mean age 77 ±8 years) who were treated surgically for a low-trauma hip fracture. This investigation is timely and appropriate because our systems of care are evolving so that increasing numbers of patients are receiving pharmacologic intervention for low bone density both before and after a fragility fracture.
The secondary outcomes of the timed up and go (TUG) test and post-TUG test pain were better in the teriparatide group, but there were no differences in radiographic fracture healing or patient-reported health status.
Although this study was designed primarily to measure the effects of the two drugs on spinal bone mineral density at 78 weeks, these secondary-outcome findings confirm the value of initiating pharmacologic intervention early on after a fragility fracture, whether it’s a bisphosphonate or anabolic agent. The orthopaedic community needs to continue leading multipronged efforts to deal with the public health issues of osteoporosis and fragility fractures.
Click here for additional OrthoBuzz posts related to osteoporosis and fragility fractures.
Marc Swiontkowski, MD
In our ongoing attempt to identify pharmacologic interventions that improve fracture healing, the sclerostin inhibitor romosozumab is a logical candidate, as it has been shown to decrease bone resorption, improve bone healing in animal and human studies, and reduce the prevalence of some fragility fractures in postmenopausal women. In the August 19, 2020 issue of The Journal, Bhandari et al. present the results of a randomized trial comparing romosozumab to placebo in the healing of tibial diaphyseal fractures treated with intramedullary (IM) nails. Tibial shaft fractures are common in adults, but even after IM nail fixation there is a significant rate of healing failure and subpar functional outcomes with this fracture type.
The study by Bhandari et al. was very well designed and conducted with high-quality data collection. In terms of the primary outcome—median time to radiographic healing—there was no significant difference between the placebo group (n=100) and 9 romosozumab groups (n=293 total, testing 3 different dose levels and 3 different frequencies). Additionally, analysis revealed no differences between placebo and romosozumab groups in median time to clinical healing or in changes in physical function from baseline. (See related OrthoBuzz post about a recent randomized trial investigating romosozumab for hip fractures.)
Kudos to Amgen for funding the trial and for allowing the 66-center, international academic consortium that conducted it to publish the results, warts and all. Such negative findings appropriately inform decisions about which compounds to investigate and about study designs for retesting the same compounds. For example, Bhandari et al. encourage further study of romosozumab in tibial-fracture patients at high risk of poor fracture healing, such as those with diabetes or patients undergoing treatment with corticosteroids.
We are likely to see many such “failures” in the search for pharmacological adjuncts to improve fracture healing, but it seems our orthopaedic community has laid out a clear roadmap for studying this important question further.
Marc Swiontkowski, MD
We have all come to realize that promising results from lab studies or preclinical trials in animal models do not always translate into meaningful clinical benefits in humans. Yet it is vitally important to perform those human trials to ascertain that knowledge. This is demonstrated by Schemitsch et al. in the April 15, 2020 edition of The Journal. The authors performed a Level I, double-blinded, randomized controlled trial comparing varying doses of romosozumab to placebo in the treatment of older patients with a hip fracture.
Romosozumab is a sclerostin-inhibiting antibody that helps increase bone formation while decreasing resorption. It is indicated to treat osteoporosis in postmenopausal women, in whom the drug has been shown to increase bone mineral density and reduce the risk of fragility fractures. In multiple preclinical studies, romosozumab has increased bone mass and bone strength in rodent osteotomy models, suggesting it might possibly promote fracture healing in people.
In the current study, Schemitsch et al. randomized patients between 55 and 95 years old who had a low-energy hip fracture amenable to internal fixation to receive 3 postsurgical subcutaneous injections of romosozumab at doses of either 70 mg (60 patients), 140 mg (93 patients), or 210 mg (90 patients), or to receive 3 placebo injections (89 patients). The primary end point was the validated “timed Up and Go” (TUG) score. The authors also measured the Radiographic Union Scale for Hip (RUSH) score, and hip pain on a visual analog scale (VAS).
The authors enrolled 325 patients, with 263 (79.2%) reaching the 24-week follow up and 229 (69.0%) reaching the 52-week follow up. They found no statistically significant between-group differences in the TUG, with all patients improving and plateauing at week 20. Similarly, there were no differences between any of the treatment arms in time to radiographic healing, RUSH scores, or VAS. The safety profile of the medication was similar between the 3 romosozumab doses and the placebo.
Romosozumab may increase bone mineral density and reduce the risk of fragility fracture in patients with osteoporosis, but when it comes to helping heal hip fractures, it did not prove to be more advantageous than placebo. This shows, yet again, that what may glitter in animal studies may not necessarily shine like gold in clinical trials with people.
Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media
Among the elderly, low-energy hip fractures are common injuries that almost all orthopaedic surgeons encounter. While operative management is typically the standard of care, there are some patients for whom nonoperative treatment is most aligned with their goals of care, usually because of chronic disease, fragility, and/or high risk of perioperative mortality.
When counseling elderly patients and family members about the risks and benefits of surgical management for a hip fracture, we have abundant data. We can estimate the length of rehabilitation, discuss the likelihood of regaining independence with ambulation, and quote the 30-day, 1-year, and 5-year mortality statistics. But what about the risks and benefits of nonoperative care? How long do these patients live? How many are alive 1 year after the fracture?
Chlebeck and colleagues attempt to answer those questions with a retrospective cohort study of 77 hip fracture patients who were treated nonoperatively and a matched cohort of 154 operatively treated hip fracture patients. Nonoperative management was chosen only after a palliative-care consult was obtained and after a thorough multidisciplinary discussion of treatment goals with the patient and family. Patients who elected nonoperative care were treated with early limited weight bearing and a focus on maximizing comfort. Researchers established a comparative operative cohort through 2:1 matched pairing, controlling for age, sex, fracture type, Charlson Comorbidity Index, preinjury living situation, preinjury ambulatory status, and presence of dementia and cardiac arrhythmia.
As one might expect, there was significantly lower mortality in the operative group. The in-hospital, 30-day, and 1-year mortality for nonoperatively treated patients was 28.6%, 63.6%, and 84.4% respectively. The mortality rates seen in the operative cohort were 3.9%, 11.0%, and 36.4% respectively. A Kaplan-Meier survival analysis revealed the median life expectancy in the nonoperative cohort to be 14 days, versus 839 days in the operative group (p <0.0001). Interestingly, the researchers found no difference in hospital length of stay between the two groups (5.4 vs. 7.7 days; p=0.10).
These results provide useful references for orthopedic surgeons to use when counseling hip fracture patients and their families. Surgical intervention remains the standard of care in most instances, and this study suggests that operative care offers a significant mortality benefit over nonoperative care even in relatively unhealthy patients, like those selected for the matched operative cohort.
This study also gives us data to help guide the expectations of patients who decide surgery is not in line with their wishes. Half of the patients who elected nonoperative care in this study died within 14 days of admission, and only 15.6% were still alive at 1 year. Additionally, choosing nonoperative care does not lengthen hospitalization, suggesting that these patients can be quickly transferred to a more comfortable setting.
Matthew Herring, MD is a fellow in orthopaedic trauma at the University of California, San Francisco and a member of the JBJS Social Media Advisory Board.
The orthopaedic community began to move away from individual fracture classifications in the mid-1980s. The basis for that shift was the need for wider recognition that fractures represent a “continuous variable,” with infinite varieties of orientations and combinations of fracture lines. Trying to fit fractures into a narrow classification system can lead to confusion and misinformation. Furthermore, surgeons often disagree when determining a fracture’s classification and, therefore, which treatment is best.
To move away from individual classification systems, orthopaedic journals have generally moved toward the compendium of fracture classifications approved by the OTA and AO. Still, there are times when a new fracture classification seems appropriate, and in the June 5, 2019 issue of The Journal, Pieroh et al. have provided us with an example that classifies fragility fractures of the pelvis (FFP). The 4-group FFP classification is based on fracture morphology with different degrees of instability and includes treatment recommendations.
The authors collected the CT scans of 60 patients from 6 different hospitals who were ≥60 years old and had sustained a pelvic fracture from low-energy trauma. These CT scans were shown to 6 experienced surgeons, 6 inexperienced surgeons, and 1 surgeon who had direct experience/training with the FFP system. Each surgeon was asked to classify the pelvic fractures according to the FFP classification. Inter- and intra-rater reliabilities for the fracture classifications were calculated from these readings, and the overall inter-rater Kappa coefficient was found to be 0.53, while the overall intra-rater Kappa coefficient was 0.46 (Kappa coefficients of 0.61 to 0.41 constitute “moderate” reliability). In terms of percent agreement, there was greater agreement between surgeons when it came to classifying FFP Group 1 fractures than for FFP Group 2 and 3 fractures. This is noteworthy because Group 3 fractures are thought to require surgical treatment, while primary treatment for Group 2 fractures is usually nonoperative.
Pelvic fractures that are associated with low bone density and low-energy trauma are becoming increasingly frequent as our population continues to skew older. Having a validated, relatively straightforward classification system like the FFP to assist us in managing these patients will be of great assistance. The sound methodology used to develop the FFP classification system and its decent reliability, face validity, and construct and criterion validity can assure all of us about the usefulness of the FFP classification as the basis for future clinical investigations and to advance the care of these patients.
Marc Swiontkowski, MD
The practice of using a geriatrician- or a hospitalist-based co-management team to care for elderly patients who are admitted to the hospital for treatment of fragility fractures or other orthopaedic procedures is now more than a decade old. These services have grown in popularity because patients are living longer with comorbidities and becoming more complex to manage medically, and because shift-based hospitalist practices have become more common. These coordinated partnerships help the hospitalist- or geriatrician-led medical team optimize the patient’s care medically, while allowing the orthopaedic surgeon to focus on the patient’s musculoskeletal condition. The consensus I have heard is that patients are better off with these co-management systems, but hard evidence has been sparse.
In the April 17, 2019 issue of The Journal, Blood et al. report on the use of the Institute for Healthcare Improvement (IHI) Global Trigger Tool to assess the adverse-event impact of a Geriatric Hip Fracture Program (GHFP). In a bivariate analysis of pre- and post-GHFP data, the authors document a decrease in the rate of adverse events and shorter lengths of stay among elderly hip-fracture patients after GHFP implementation. However, multivariable analysis confirmed only a trend toward decreasing adverse-event rates after the implementation of the program. This study also seems to confirm what many of us already know empirically—that hip-fracture patients with severe medical comorbidities (i.e., a high Charlson Comorbidity Index) are at increased risk of adverse events no matter what system of care they receive.
Still, what most orthopaedic surgeons have felt was a “no-brainer,” coordinated approach to optimizing patient care and decreasing adverse events now has more evidence of effectiveness. Because such programs decrease both adverse events and length of stay among elderly patients hospitalized for a hip fracture, orthopaedic surgeons everywhere should advocate for increased geriatrician training to support this movement. Furthermore, these findings should encourage further research into additional patient-centric medical care strategies that could improve outcomes for these patients.
Marc Swiontkowski, MD