Every month, JBJS publishes a Specialty Update—a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all OrthoBuzz Specialty Update summaries.
This month, OrthoBuzz asked Theodore Choma, MD, co-author of the June 21, 2017 Specialty Update on spine surgery, to select the five most clinically compelling findings from among the more than 40 studies cited in the article.
Biomaterials and Biologics
A multicenter randomized prospective trial compared osteogenic protein-1 (OP-1, also known as bone morphogenetic protein [BMP]-7) combined with local autograft to iliac crest autograft combined with local autograft in posterolateral lumbar fusion. Based on computed tomography (CT) scan assessments, the authors found a 54% fusion rate in the OP-1 group and a 74% fusion rate in the iliac crest group. OP-1 appears to be a poor substitute for iliac crest autograft for achieving posterolateral lumbar fusion.
Adult Spinal Deformity (ASD)
We continue to elucidate the risks and morbidity of adult degenerative spinal deformity surgery. The Scoli-Risk-1 study,1 a Level-III multicenter, prospective observational study, reported on 272 patients with ASD treated surgically. Twenty-two percent of the patients were discharged from the hospital with a decline in the lower-extremity motor score, while only 13% demonstrated improvement. However, by 6 months postoperatively, 21% demonstrated improvement, 69% demonstrated maintenance, and 11% continued to demonstrate lower-extremity motor decline.
Spinal Cord Injury
A Level-I, randomized, crossover trial2 examined whether the character of neuropathic pain following spinal cord injury determined the response to 300 mg/day of either pregabalin or oxcarbazepine. Both anticonvulsant medications significantly improved neuropathic pain in these patients. A subgroup analysis demonstrated that oxcarbazepine was more effective in patients without evoked pain and pregabalin was more effective in patients with evoked pain.
Lumbar Degenerative Spondylolisthesis
To address the consequences of fusion along with decompression in degenerative lumbar spondylolisthesis, a Level-I, randomized controlled trial3 specifically compared laminectomy only with laminectomy plus fusion among 66 patients with stable degenerative spondylolisthesis and symptomatic lumbar stenosis. Patients in the fusion group had significantly higher SF-36 scores at 2, 3, and 4 years, but the groups did not differ with respect to ODI scores at 2 years. The authors reported a significantly higher reoperation rate (34% compared with 14%) in the decompression-only group over the 4-year follow-up, but patients who underwent decompression with fusion began to have an increase in the probability of reoperation 36 months after surgery.
We have more evidence of the effectiveness of vertebral cement augmentation for osteoporotic thoracolumbar compression fractures. The authors of a level-I systematic review and meta-analysis examined randomized controlled trials comparing vertebroplasty with conservative treatment or placebo/sham and identified 11 relevant studies involving 1,048 subjects. The meta-analysis found that patients receiving percutaneous vertebroplasty (n = 531) had lower pain ratings at 1 to 2 weeks, 2 to 3 months, and 1 year. The effect size of vertebroplasty was significant and close to the minimal clinically important difference (MCID).
- Lenke LG, Fehlings MG, Shaffrey CI, Cheung KM, Carreon L, Dekutoski MB, Schwab FJ, Boachie-Adjei O, Kebaish KM, Ames CP, Qiu Y, Matsuyama Y, Dahl BT, Mehdian H, Pellis´e-Urquiza F, Lewis SJ, Berven SH. Neurologic outcomes of complex adult spinal deformity surgery: results of the prospective, multicenter Scoli-RISK- 1 study. Spine (Phila Pa 1976). 2016 Feb;41(3):204-12.
- Min K, Oh Y, Lee SH, Ryu JS. Symptom-based treatment of neuropathic pain in spinal cord-injured patients: a randomized crossover clinical trial. Am J Phys Med Rehabil. 2016 ;95(5):330–8
- Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34.
OrthoBuzz has published several posts about osteoporosis, fragility fractures, and secondary fracture prevention. In the May 17, 2017 edition of JBJS, Bogoch et al. add to evidence suggesting that a coordinator-based fracture liaison service (FLS) improves engagement with secondary-prevention practices among inpatients and outpatients with a fragility fracture.
The Division of Orthopaedic Surgery at the University of Toronto initiated a coordinator-based FLS in 2002 to educate patients with a fragility fracture and refer them for BMD testing and management, including pharmacotherapy if appropriate. Bogoch et al. analyzed key clinical outcomes from 2002 to 2013 among a cohort of 2,191 patients who were not undergoing pharmacotherapy when they initially presented with a fragility fracture.
- Eighty-four percent of inpatients and 85% of outpatients completed BMD tests as recommended.
- Eighty-five percent of inpatients and 79% of outpatients who were referred to follow-up bone health management were assessed by a specialist or primary care physician.
- Among those who attended the referral appointment, 73% of inpatients and 52% of outpatients received a prescription for anti-osteoporosis medication.
The authors conclude that “a coordinator-based fracture liaison service, with an engaged group of orthopaedic surgeons and consultants…achieved a relatively high rate of patient investigation and pharmacotherapy for patients with a fragility fracture.”
Spring and Summer 2017 are busy seasons for Own the Bone, the American Orthopaedic Association’s national post-fracture, systems-based, multidisciplinary fragility fracture prevention initiative:
On Thursday, May 4, at 5:00pm CDT (6:00pm EDT) Paul A. Anderson, MD, FAOA, from the University of Wisconsin, and Karen Cummings, PA-C, from the University of Michigan, will discuss the components of a successful secondary fracture prevention program.
Join the National Association of Orthopaedic Nurses (NAON) and The American Orthopaedic Association for this full-day event on Friday, June 23. Attendees will receive a Fragility Fracture Symposium Certificate of Completion and continuing education credit.
Join Physician Assistants in Orthopaedic Surgery (PAOS) and Own the Bone for a full-day fragility fracture and bone health workshop on the first day of the PAOS Annual Conference, Monday, August 21, in Baltimore.
On Thursday, February 23, 2017, at 6:00 pm EST, the Own the Bone initiative will offer a webinar titled “Atypical Fractures and Osteoporosis Medication Considerations”
James Goulet, MD, from the University of Michigan, will discuss atypical fractures and other rare outcomes of the use of osteoporosis medication, including what to look for and how to treat these occurrences. He will also address drug holidays, and how and when to continue treatment on these complex cases.
The American Orthopaedic Association (AOA) developed Own the Bone as a quality improvement program to address the osteoporosis treatment gap and prevent subsequent fragility fractures.
0.75 hour of CME credit is available.
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Brett A. Freedman, MD.
In the December 21, 2016 edition of the Journal of Bone & Joint Surgery, Bunta, et al. published an analysis of data from the Own the Bone quality improvement program collected between January 1, 2010 and March 31, 2015. Over this period of time, 125 sites prospectively collected detailed osteoporosis and bone health-related data points on men and women over the age of 50 who presented with a fragility fracture.
The Own the Bone initiative is more than a data registry; it’s a quality improvement program intended to provide a paradigm for increasing the diagnostic and therapeutic recognition (i.e. “response rate”) of the osteoporosis underlying fragility fractures among orthopaedic practices that treat these injuries. With more than 23,000 individual patients enrolled, and almost 10,000 follow-up records, this is the most robust dataset in existence on the topic.
This initiative has more than doubled the response rate among orthopaedic practices treating fragility fractures. The number of institutions implementing Own the Bone grew from 14 sites in 2005-6 to 177 in 2015. According to Bunta et al., 53% of patients enrolled in the Own the Bone quality Improvement program received bone mineral density testing and/or osteoporosis therapy following their fracture.
Own the Bone was a natural progression of rudimentary efforts that came about during the Bone and Joint Decade, and it marks a strategic effort on the part of the American Orthopedic Association to identify and treat the osteoporosis underlying fragility fractures. Multiple studies have demonstrated that only 1 out of every 4 to 5 patients who present with a fragility fracture will receive a clinical diagnosis of osteoporosis and/or active treatment to prevent secondary fractures related to osteoporosis. Ample Level-1 evidence demonstrates that the initiation of first-line agents like bisphosphonates, or second-line agents when indicated, can reduce the chance of a subsequent fragility fracture by at least 50%. We know these medicines work.
We also know that osteoporosis is a progressive phenomenon. Therefore, failing to respond to the osteoporosis underlying fragility fractures means we as a medical system fail to treat the root cause in these patients. The fracture is a symptom of an underlying disease that needs to be addressed or it will continue to produce recurrent fractures and progressive decline in overall health.
The members of the Own the Bone initiative must be commended for their admirable work. We as an orthopedic community need to attempt to incorporate lessons learned through the Own the Bone experience into our practice to ensure that we provide complete care to those with a fragility fracture. The report from Bunta et al. represents a large—but single—step forward on the journey toward universal recognition and treatment of the diminished bone quality underlying fragility fractures. I look forward to additional reports from this group detailing their continued success in raising the bar of understanding and intervention.
Brett A. Freedman, MD is an orthopaedic surgeon specializing in spine trauma and degenerative spinal diseases at the Mayo Clinic in Rochester, MN.
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
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Brett A. Freedman, MD, in response to a study published in JAMA about a new agent to prevent fractures in postmenopausal women with osteoporosis.
The August 16, 2016 issue of JAMA published the results of the ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial. This 28-site randomized trial allocated postmenopausal women with low bone mineral density (BMD) and/or a prior fragility fracture into one of three arms: abaloparatide (80 µg subcutaneously, daily ) vs. daily placebo injection vs. teriparatide (20 µg subcutaneously, daily). The primary end point was new vertebral fracture over the 18-month trial.
As expected, both anabolic agents significantly outperformed placebo, with incident vertebral fractures occurring in only 4 subjects in the abaloparatide arm (0.6%) and 6 in the teriparatide arm (0.8%), while there were 30 in the placebo arm (4.2%). Although the study was not powered to evaluate differences between the two anabolic agents, the results suggest that abaloparatide and teriparatide performed essentially the same over the 18-month period.
In an accompanying commentary,1 Cappola and Shoback note that institutional review boards (IRBs) approved a prospective clinical trial protocol in which patients with known osteoporosis and/or a prior fragility fracture were allowed to be randomized to a non-treatment arm for 18 months. Subjects whose BMD dropped more than 7% from baseline and those who experienced an incident fracture during the trial “were offered an option to discontinue and receive alternative treatment,” but in some sense IRB approval of this protocol implicitly acknowledged that osteoporosis is undertreated.
Turning back to the study itself, I noted with interest that subjects who had regularly used bisphosphonates in the last 5 years or denosumab in the last year were excluded. So, none of the 2463 subjects who were randomized had received any active treatment for osteoporosis in the 1 to 5 years prior to enrollment, despite the fact that the average T-score in the lumbar spine (-2.9 for all 3 arms) was in the osteoporotic range and that almost one-third of subjects had had at least one prior fragility fracture.
This is a sad commentary on “our” (meaning all providers involved in bone health) continued inability to diagnose and treat osteoporosis effectively. Despite the “National Bone and Joint Health Decade” (2002-2011) and our continued attempts to “Own the Bone,” we have made little progress in recognizing and treating the osteoporosis underlying the fragility fractures that we so frequently treat. Colleagues of mine and I published that only 38% of patients in 2002 with clinically diagnosed vertebral compression fragility fractures were receiving active treatment for osteoporosis.2 Over the ensuing decade, Solomon et al. showed that that figure actually decreased to 20%.3
This JAMA study provides empiric Level-I support for the efficacy of another anabolic agent to treat osteoporosis. Cost, subcutaneous delivery, and osteosarcoma concerns have limited the only FDA-approved anabolic osteoporosis medication, teriparatide, to second-line status, behind bisphosphonates. If and when approved, abaloparatide will probably bump up against the same limitations. Still, the parathyroid hormone receptor agonists are particularly pertinent to orthopaedic surgeons, because they are the most effective secondary fracture prevention agents—and the only ones that show meaningful improvement in bone mineral density. This bone-building property has also led to progressive acceptance of teriparatide as an important perioperative adjunct for instrumented spinal fusion surgery in patients with known osteoporosis.
However, as has been repeatedly shown, parathyroid receptor agonists only work when they are prescribed, and they are only prescribed when osteoporosis is diagnosed.2,3 Patients with incident clinical fragility fractures need to be effectively educated about osteoporosis, its treatment, and the impact of failing to treat it. Orthopaedic surgeons need to continue to set the signal flares and advocate for our patients to receive effective treatment for all their chronic musculoskeletal illnesses, not the least of which is osteoporosis.
- Cappola AR, Shoback DM. Osteoporosis Therapy in Postmenopausal Women With High Risk of Fracture. JAMA. 2016 Aug 16;316(7):715-6.
- Freedman BA, Potter BK, Nesti LJ, Giuliani JR, Hampton C, Kuklo TR. Osteoporosis and vertebral compression fractures-continued missed opportunities.Spine J. 2008 Sep-Oct;8(5):756-62.
- Solomon DH, Johnston SS, Boytsov NN, McMorrow D, Lane JM, Krohn KD. Osteoporosis medication use after hip fracture in U.S. patients between 2002 and 2011. J Bone Miner Res. 2014 Sep;29(9):1929-37.
In the July 20, 2016 issue of The Journal, Louer et al. detail the association between distal radial fractures and poor balance. We have long understood that inherently poor balance was a major contributor to fall risk, and now we have more hard evidence thanks to this research team.
In this case-control evaluation comparing 23 patients ≥65 years of age who had sustained a low-energy distal radial fracture with 23 age- and sex-matched control patients, the authors found that those in the fracture cohort:
- Demonstrated poorer balance based on dynamic motion analysis (DMA) scores
- Were able to perform the balance test for significantly less time
- Rated themselves as having worse mobility
Among both cohorts, only 3 patients had completed an evaluation of or treatment for balance deficiencies.
The orthopaedic community has begun to pay attention to fragility fracture risk reduction through programs such as the AOA’s “Own the Bone” initiative, which focuses on identifying patients with fragility fracture and applying evidence-based treatment and prevention guidelines. Fragility fracture programs led by nurse practitioners or physician assistants have gained traction in many centers and have been proven effective in identifying at-risk patients and providing appropriate follow-up care.
Any intervention for patients presenting with the first fragility fracture must include assessing fall risk. Home evaluations addressing hazards such as loose carpets, poor lighting, and poorly designed stairway transitions are critical. We also know that activities such as tai chi, low-impact aerobics, and yoga, when regularly practiced, can help preserve balance. Now, developing programs that actually improve postural balance must be part of our collective research agenda as we attempt to address the major public health issue of fall-related fragility fractures.
Marc Swiontkowski, MD
On Thursday, June 23, 2016, the American Orthopaedic Association and the National Association of Orthopaedic Nurses will host a full-day symposium focused on how to establish and run a fracture liaison service.
- When: Thursday, June 23, 2016, 9:00 am to 5:30 pm
- Where: The Westin Seattle, Seattle, WA
Learn from national and local experts and network with other clinicians interested in secondary fracture prevention programs. JBJS Editor-in-Chief Marc Swiontkowski, MD will be one of the presenters.
Register before June 1 to receive reduced pricing.
On Thursday, December 10, 2015, from 6:00 to 6:30pm EDT, the Own the Bone initiative will offer a free webinar titled “Vitamin D in Chaos: A Common Sense Approach for Orthopaedics.”
Neil C. Binkley, MD, from the University of Wisconsin will review the physiology of vitamin D, current approaches to 25(OH)D testing, and recommendations for treatment of those whose levels are low. Defining “low” vitamin D status remains extremely controversial, but many fracture patients have vitamin D inadequacy that may contribute to low bone mass and fragility fracture risk.
The American Orthopaedic Association (AOA) developed Own the Bone as a quality improvement program to address the osteoporosis treatment gap and prevent subsequent fragility fractures.