Tag Archive | JAMA

In My Hands, There’s a Dog Leash

As a journalist covering symposia at the 2019 AAOS Annual Meeting last week, I repeatedly heard the phrase “in my  hands…,” referring to a surgeon’s individual experience with this or that technique. That got me to thinking about a research letter published in the March 6, 2019 issue of JAMA Surgery. This retrospective cross-sectional analysis of emergency department data revealed that the annual number of patients ≥65 years old presenting to US emergency departments with fractures associated with walking leashed dogs more than doubled during 2004 to 2017. Women sustained more than three-quarters of those fractures, and while the hip was the most frequently fractured body part, collectively, the upper extremity was the most frequently fractured region. Slightly more than one-quarter of those patients were admitted to the hospital.

The authors rightly pinpoint the “gravity of this burden”; the hip-fracture data alone are worrisome. And in a related online article by hand and wrist surgeons from Rush University Medical Center (titled “Doggy Danger”), the focus is on the many injuries that the human leash-holding apparatus can sustain. The authors of the JAMA Surgery research letter and the Rush authors offer common-sense advice for all us older dog walkers out there, including:

  • Dog obedience training that teaches Bowser not to pull or lunge while on leash
  • Selection of smaller dogs for older people contemplating acquiring a canine companion
  • Holding the leash in your palm, not wrapping it around your hand
  • Paying attention to where you walk, and being situationally aware (That means not texting while your dog is momentarily sniffing to see who peed on that post.)
  • Selecting footwear that is appropriate for the terrain and environmental conditions during your walk

To these tidbits I would add finding a safe area where your dog can “be a dog” off-leash, preferably with other dogs and people. Socializing is good for both species, and most dog trainers and owners agree that “a tired dog is a good dog.”

The research letter states that a “risk-benefit analysis with respect to dog walking as an exercise alternative is essential,” and the authors do a concise job of quantifying fracture risk and suggesting risk-reduction strategies. The list of benefits from dog walking is too long to itemize here; suffice to say that the advantages run the gamut from physical to mental to spiritual. But let’s be safe and sensible out there. We owe it to our families (dogs included, of course) and to all those overworked orthopaedic trauma surgeons to stay on the sidewalks and in the forests and fields–and out of the ER.

Lloyd Resnick
JBJS Developmental Editor

Guest Posts: Two Views on Casting for Unstable Ankle Fractures

ankle_fracture_2016-10-19OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent JAMA study, the following two commentaries come from Chad Krueger, MD, and Shahriar Rahman, MS.

“Hmmm…. Maybe I’m operating on too many ankle fractures.” That was my first thought as I read the abstract of the recent Willett et al. study in JAMA. They conducted a well-designed, randomized controlled trial that compared operative and nonoperative treatment of unstable ankle fractures, using the Olerud-Molander Ankle Score at 6 months postoperatively as the primary outcome measure.

On the surface, it appeared as though patients who were treated nonoperatively with close contact casting did just as well as those who underwent operative intervention. This seemed to be not only the case with the primary outcome measure, but also with secondary outcomes such as quality of life, pain, and patient satisfaction.  “Do less” appeared to be the main message of the abstract. However, I became more skeptical after critically reading the entire article.

First off, the study was designed to determine differences between treatment groups, not to prove that they were equivalent. Finding no difference is not the same as showing equivalence, and the article did the former, not the latter.

There are also a few things about the study that may limit the wide applicability of the findings and provide some solace to surgeons like me who feel that fixing unstable ankle fractures provides superior outcomes. First, only initial radiographs were used to determine who had unstable ankle fractures. Stress radiographs were an exclusion criterion, so for the many ankle fractures that require such imaging to determine instability, the results from Willett et al. may not apply.

Second, the study was designed to compare these treatments in older adults. The mean ages of operative and nonoperative groups were 69.8 and 71.4 years old, respectively, and almost 75% of both groups were female. While bone density was not measured in either group, it is likely that many patients included in this study had osteoporotic disease, which introduces another potential variable when interpreting the findings.

Furthermore, nearly 20 percent of all patients who initially were treated with casting developed some type of complication that required conversion to surgical fixation. This finding, plus the fact that all casts were applied by surgeons in the operating room with patients under general or spinal anesthesia, suggests that treating unstable ankle fractures with surgical fixation in a single visit would perhaps provide the most definitive treatment.

So, I will probably continue to offer patients with unstable ankle fractures surgical fixation. I have never tried the close contact casting that was described in the article, and I suspect, despite the authors’ claim of evidence to the contrary, that there is a significant learning curve associated with that technique. If about one out of every five patients I perform casting on as definitive treatment ends up needing additional procedures, I am not sure I have done the patient justice. While this study provides interesting evidence and may apply to a small subset of my older patients, I think it has limited applicability in other patients who present with unstable ankle fractures.

Chad Krueger, MD is a military orthopaedic surgeon at Womack Army Medical Center in Fort Bragg, North Carolina.

*     *     *     *     

The Willett et al. study in JAMA indicates that some patients older than 60 years with unstable ankle fractures can be treated by modified casting alone, without the need for operative stabilization and fixation. The study protocol allowed conversion to surgery among patients randomized to casting if reduction was not possible during the initial procedure or was lost within the first 3 weeks.

One hundred surgeons applied close contact casting at 24 major trauma centers and general hospitals in the UK. After 6 months, the mean Olerud-Molander Ankle Score was 66.0 in the surgery group vs 64.5 in the casting group—no significant difference in the primary outcome.

Secondary outcomes showed that the rate of radiographic malunion was 15% in the casting group compared with 3% in the surgery group. Conversion from casting to operative treatment was high: of the 311 patients randomized to casting, 70 (23%) were ultimately treated by internal fixation, including 18 never treated with close contact casting and 52 who lost reduction and required conversion to internal fixation. Rates of infection and wound complications were 10% in the surgical group versus 1% in the casting group. Additional operating room procedures were required in 6% of the surgery group and 1% of the casting group. Casting required less operating room time compared with surgery.

The overall similarity in clinical outcomes in this study challenges the importance of restoring exact ankle-joint congruence in older adults and suggests that function and pain are not as closely related to malunion as many clinicians believe. Neither method yielded an entirely satisfactory outcome in older adults. In older patients with lower demand, shorter life expectancy, lesser bone and tissue quality, and diminished capacity for healing, the rates of delayed or infected wound healing and loss of implant fixation are greater.

Casting may be an imperfect alternative to surgery particularly in developing countries. One must remember, however, that plaster technique is an art. Achieving the successful outcomes with close contact casting as described by Willett et al. is likely to pose a learning curve. Further studies are needed to identify which specific patients are most and least likely to benefit from casting.

Shahriar Rahman, MS is a consultant orthopaedic surgeon at the Ministry of Health & Family Welfare in Bangladesh.

Guest Post: Osteoporosis Treatment Still Lacking

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.

References:

  1. Cappola AR, Shoback DM. Osteoporosis Therapy in Postmenopausal Women With High Risk of Fracture. JAMA. 2016 Aug 16;316(7):715-6.
  1. 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.
  1. 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.

Nebulous Controls, Noncompliance Mar JAMA Low Back Pain Study

OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Brett A. Freedman, MD, in response to a recent JAMA study on treatment for chronic low back pain.

Chronic low back pain (CLBP) is truly a bio-psycho-social disease. Cherkin et al. in the March 22/29, 2016 issue of JAMA published a randomized clinical trial comparing the performance of two psychologically focused interventions for CLBP with usual care.

The authors randomly assigned 342 subjects solicited from an integrated health plan in the state of Washington who had at least 3 months (average 7.3 years) of nonspecific CLBP to one of three cohorts: mindfulness-based stress reduction (MBSR), cognitive behavioral therapy (CBT), or usual care. MBSR is a pain self-management program that incorporates yoga and focuses on “increasing awareness and acceptance of moment-to-moment experiences.”  The two therapy arms included eight 2-hour sessions.

The primary and secondary outcomes were computed values on patient-reported outcome (PRO) instruments compared from baseline out to one year.  According to intention-to-treat analysis, MBSR and CBT resulted in a significantly higher chance of patients obtaining a clinically meaningful response, which equated to a >30% improvement in scores on the modified Roland Disability Questionnaire at 26 weeks after enrollment (61% for MBSR vs. 58% for CBT vs. 44% for usual care).

While these findings are interesting and support the notion of more research into non-pharmacological and non-interventional CLBP treatment, the impact of this study is limited by inherent flaws.  The investigators’ intent was to have the usual care group represent a control group.  However, the usual care cohort was far from controlled.  At the time of enrollment, those randomized to the usual care cohort were each given $50 and were set free to “seek whatever treatment [for their CLBP], if any, they desired.”   The resultant placebo effect of receiving active treatment (i.e. MBSR, CBT) versus no prescribed treatment (i.e. usual care cohort) is substantial.

Also, aside from reporting their collected PRO data, the authors say little about what happened to the usual care group during this trial, further making this cohort too nebulous to serve as a meaningful comparator.  If this cohort is excluded from the analysis, this becomes a negative-findings study, since there were no significant differences in any measured outcome between the MBSR and CBT cohorts, aside from mental health measures, which were significantly improved following CBT.

Another major flaw is the very high rates of patient noncompliance with treatment.  Only 51% of the subjects in the 2 therapy arms attended at least 6 of the sessions, and 13 subjects (11%) in each of the active-therapy groups attended no sessions.  A substantial minority of patients failed to meaningfully participate in their prescribed intervention, yet their improved outcomes are attributed to the impact of these programs. If the same lack of adherence to protocol occurred in a pharmacological or surgical study, the results would be ignored and the article would likely go unpublished, or at least not published in a high-impact journal such as JAMA.

In conclusion, the greatest merit of this study is the research question it poses.  We certainly need more work on this subject, but unfortunately this particular study does little to further advance our understanding of the best practices for approaching the bio-psycho-social disease we call CLBP.

Brett A. Freedman, MD is an orthopaedic surgeon specializing in spine trauma and degenerative spinal diseases at the Mayo Clinic in Rochester, MN.

Thank You, Dr. Page

The July 7, 2015 edition of JAMA includes a moving and powerful essay from orthopaedic surgeon Alexandra Page, MD, titled “Stopping Time.”

We in orthopaedic surgery rarely stop to think about the important foundations of our personal and professional lives. Dr. Page’s very intimate story begs us all to pause, take stock, and be grateful. I thank her for sharing her story with our community, and I encourage everyone to read it.

Marc Swiontkowski, MD

JBJS Editor-in-Chief

JUPITER Says Statins Don’t Deliver Fracture Benefit

When it comes to heart disease and stroke, statins are remarkably effective drugs, and some observational studies have suggested that these lipid-lowering medications might even reduce the risk of bone fractures. But a secondary analysis of the JUPITER trial—a randomized study designed primarily to determine whether rosuvastatin (Crestor) had any effect on cardiovascular outcomes in people who were not candidates for statins—found that statin therapy did not reduce fracture risk. The study population included more than 17,800 men and women with a mean age of 66.

The JUPITER trial was halted after less than two years because of the significant cardiovascular benefits seen in the Crestor group. During that 1.9-year period, 221 imaging-confirmed fractures occurred in the Crestor group, while 210 fractures occurred in the placebo group, according to a paper published online in JAMA Internal Medicine. This fracture-focused secondary analysis was prespecified before the trial started, not run as an afterthought, which adds credibility to the findings.

Early Results from Alternative Medical-Liability Reforms

According to data published in the New England Journal of Medicine in 2011, nearly 15 percent of orthopaedic surgeons are likely to face a medical liability claim each year, and the cumulative likelihood of an orthopaedic surgeon facing such a claim by the age of 45 is 88 percent. In addition to statistics like this that suggest a flawed system, the tort-based medical malpractice system has not proven to deter substandard care or improve patient safety–and neither has the tort-reform approach to improving the existing liability environment.

Alternatives to tort reform may provide a ray of hope. A recent JAMA article summarized what it calls “a welcome influx of creative initiatives that transcend traditional reforms.” The Mello et al. article evaluates nontraditional approaches that were or are being tested during demonstration projects supported by the Agency for Healthcare Research and Quality (ARHQ). The article devotes much of its space to the so-called communication-and-resolution approach pioneered by the Lexington, Kentucky VA hospital and the University of Michigan Health System. The worth-reading article also covers mandatory presuit notification and apology laws, judge-directed negotiation programs, clinical guideline-based safe-harbor laws, and administrative compensation systems.

In a recent AAOS Now article citing possible barriers to widespread implementation of these and other no-fault approaches to medical liability reform, David Sohn, MD, JD, identifies the trial lawyer lobby as probably the biggest political hurdle that needs to be overcome.

Nonoperative Knee-Pain Treatments: Acupuncture—No, Bracing—Yes

Two recent studies revealed that valgus bracing may be more effective than acupuncture for treating knee osteoarthritis.

A JAMA study of nearly 300 people 50 and older with chronic knee pain and morning stiffness found that 12 weeks of acupuncture, delivered via both needles and laser,  provided no substantial pain or function benefits at 12 weeks or one year, relative to no acupuncture or a sham laser procedure. One interesting aspect of this study was its so-called Zelen design; participants were consented after randomization, and those randomized to receive no acupuncture were unaware that they were in an acupuncture trial. According to the authors, “Zelen designs can reduce the risk of bias in a treatment trial in which knowledge of the intervention may influence recruitment…and outcomes.”

Conversely, a meta-analysis of six randomized studies totaling more than 400 patients in Arthritis Care and Research found that a valgus knee brace can improve pain and function in people with medial knee osteoarthritis. The analysis examined trials that compared valgus bracing with no orthosis and with other types of orthoses, such as neoprene sleeves. In the former comparison, the valgus brace yielded improvements in both pain and function; in the latter comparison, valgus bracing improved pain but not function. An editorialist commenting on the findings opined that the clinical goal going forward should be to identify those patients who are most likely to benefit from this type of bracing and who will comply with instructions for use.

Post-Rehab At-Home Exercise Boosts Mobility after Hip Fracture

A home-based exercise program modestly improved physical function in older adults who completed a standard rehabilitation program after a hip fracture, according to a recent JAMA study.

Half of nearly 200 older adults with limited function after finishing rehab were randomized to home exercises; the other half received in-home and phone-based nutrition education. The exercise group learned functional tasks (such as standing from a chair and climbing a step) during three hour-long home visits by a physical therapist, and then performed the tasks on their own three times weekly for six months. After six months, the exercise group had better scores of physical function — as measured by the Short Physical Performance Battery and Activity Measure for Post-Acute Care — than the control group.

While the clinical importance of these findings remains to be established, the results suggest that an extended period of structured at-home rehabilitation could help older patients sidestep some of the long-term functional limitations that often persist following a hip fracture.