Archive | July 2015

What’s New in Spine Surgery: Level I and II Studies

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. Here is a summary of selected findings from Level I and II studies cited in the June 17, 2015 Specialty Update on spine surgery:

  • A database study to determine the prevalence of venous thromboembolic events after spinal fusion found that risk factors for such events included hypercoagulability, certain medical comorbidities, older age, and male sex.
  • An RCT comparing allograft alone versus allograft plus bone marrow concentrate to accomplish spine fusion in adults with spondylolisthesis found very poor union rates in both groups, although allograft with bone marrow concentrate delivered slightly better results.
  • A meta-analysis of five studies (253 patients) found no pain or functional differences when unilateral percutaneous kyphoplasty was compared with bilateral (same-vertebra) kyphoplasty for osteoporotic compression fractures. The unilateral approach was associated with shorter operative times, however.
  • An RCT comparing the analgesic efficacy and clinical utility of gabapentin, pregabalin, and placebo in patients undergoing spinal surgery found that pregabalin outperformed the other two interventions immediately after surgery postoperative and up to three months postoperatively.
  • In an RCT comparing open-door to French-door laminoplasty for cervical compressive myelopathy, both techniques were found to be equivalent in terms of neurological recovery and perioperative complications, but patients receiving the open-door technique had more kyphosis and less cervical range of motion postoperatively.
  • An update to a 2002 Cochrane review found no significant outcome differences between supervised and home-exercise rehabilitation programs after lumbar disc surgery.
  • A systematic review/meta-analysis showed that radiofrequency denervation of facet joints is more effective than placebo in achieving functional improvement and pain control in patients with chronic low back pain.
  • A Level II diagnostic study concluded that with a magnification of 150% and a good pair of flexion and extension radiographs following anterior cervical arthrodesis, pseudarthrosis was noted with >1 mm of motion between fused interspinous processes with 96.1% specificity and a positive predictive value of 96.9%.
  • A Level I therapeutic study comparing the efficacy of intravenous tranexamic acid, epsilon-aminocaproic acid, and placebo to reduce bleeding in 125 adolescent patients undergoing posterior fusion for idiopathic scoliosis found less intraoperative and postoperative blood loss and higher hematocrit levels with the antifibrinolytics than with placebo. However, transfusion requirements were no different between the groups.
  • A randomized comparison of navigated versus freehand techniques for pedicle screw insertion during lumbar procedures found that surgeon radiation exposure with freehand technique is up to 10 times greater than with use of navigation.

Calculating Individual Complication Rates Is Complicated

Rating hospitals on the basis of complications is one thing, but when you publish complication-rate scorecards for individual surgeons, as ProPublica did recently with nearly 17,000 surgeons nationwide, things can get personal.

ProPublica, an independent investigative-journalism group, examined five years of Medicare records for eight common elective procedures, three of which—knee and hip replacements and spinal fusions—orthopaedists perform. For each of the eight procedures, a panel of at least five physicians, including relevant specialists, reviewed 30-day readmission data to determine whether the readmission represented a complication; if a majority agreement was not achieved, the case was excluded from analysis. The analysis also excluded trauma and other high-risk cases, along with cases that originated in emergency departments.

Overall, complication rates were 2% to 4%. About 11% of the doctors accounted for about 25% of the complications.

In a ProPublica article about the scorecard, Dr. Charles Mick, former president of the North American Spine Society, is quoted as saying, “Hopefully, [the scorecard] will be a step toward a culture where transparency and open discussion of mistakes, complications, and errors will be the norm and not something that’s hidden.”  For its part, the AAOS responded with a press release that welcomed transparency but cautioned that “the surgical complication issue is much more complex, and cannot be effectively addressed without considering all of the variables that impact surgery, care, and outcomes.”

Pre-emptively, ProPublica clarified its methods in a separate article. Any 30-day readmission that the panel determined to be a complication was assigned to the surgeon who performed the original procedure. After compiling a raw complication rate for each doctor, researchers screened each patient’s health record and assigned a “health score.” That health score was used as part of a mixed-effects statistical model to determine an individual’s adjusted complication rate. No rate is reported if a surgeon performed a procedure fewer than 20 times.

Over the years, physician groups have complained that conclusions derived from Medicare data are inherently flawed, an argument that one orthopaedist made in the ProPublica article, citing the “multitude of inaccurate and confusing information that is provided to state and federal organizations.” Interestingly, two renowned patient-outcome experts cited in the ProPublica article came to separate conclusions. Dr. Thomas Lee, chief medical officer at healthcare-metrics consultancy Press Ganey, was quoted as saying that “the methodology was rigorous and conservative,” while Dr. Peter Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins, told ProPublica in an email just prior to the scorecard release that “it would be highly irresponsible to present this to the public in its current form, or to make an example of any surgeon based on faulty data analysis.”

In another take on ProPublica’s ratings, radiologist Saurabh Jha spins a yarn on KevinMD  of two fictional orthopaedists, Dr. Cherry Picker and Dr. Morbidity Hunter. The moral of this tale, Dr. Jha says, is that ProPublica’s scorecard is “a reservoir of Sampson’s paradox…when the data says ‘bad surgeon,’ the surgeon might in fact be a Top Gun—a technically gifted Morbidity Hunter—the last hope of the poor and sick.”

Obviously the ProPublica scorecard has touched many a nerve among hip/knee-reconstruction and spine surgeons. Have you looked at your numbers? What do you think? Please join the discussion by clicking on the “Leave a comment” button in the box above, next to the article title.

JBJS Editor’s Choice—Telerehab Just as Good as Hands-On Rehab after TKA

swiontkowski marc colorI selected this study from the July 15, 2015 Journal because it highlights where we need to be headed with innovation for musculoskeletal care. Health care budget pressures and patient satisfaction measurements are pushing us to develop cost-effective care that also offers greater patient convenience.

Dr. Helene Moffet and her colleagues conducted a well-designed, randomized controlled trial, and they found that in-home telerehabilitation was “noninferior” to face-to-face delivery of home-rehab services among more than 200 post-TKA patients. These are important findings, but I surmise that only patients who preferred care in the home and/or were equipped to manage the requisite technology agreed to be randomized. In fact, as Dr. Mark Spangehl observed in his accompanying Commentary, more than one-third of patients assessed for eligibility declined to participate in the study. “Patients who are less motivated or less computer savvy or are technologically adverse may not be able to navigate this type of system,” Dr. Spangehl wrote. Other patients will simply require the human touch to motivate them to work on strength, gait, and range of motion.

So, in addition to developing innovations like this that lower the total cost of care while maintaining or improving its quality, we need to conduct research that will identify the patients who will do well with  innovation and those who will do better with more traditional care. Today, this two-pronged type of systems-innovation research is essential for patients and health systems worldwide.

Marc Swiontkowski, MD

JBJS Editor-in-Chief

Article Exchange with Journal of Orthopaedic & Sports Physical Therapy (JOSPT)

Those of you who receive our table of contents alert emails may have noticed the addition of a monthly link to an article in the Journal of Orthopaedic & Sports Physical Therapy.  JBJS recently launched this “article exchange” collaboration with JOSPT to support multidisciplinary integration, continuity of care, and excellent patient outcomes in orthopaedics and sports medicine.

Every month, the Editors-in-Chief of each journal— Guy Simoneau, PT, PhD, ATC for JOSPT and Marc Swiontkowski, MD for JBJS—select an article that is important to the audience of the other journal. Selected exchange articles are made available to JOSPT and JBJS subscribers free of charge, through links in each journal’s Table of Contents e-mail alerts.

We hope our readers find this expanded partnership with JOSPT useful!

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JBJS Classics: The “Game Changer” for Managing Femoral Shaft Fractures

JBJS-Classics-logoEach month during the coming year, OrthoBuzz will bring you a current commentary on a “classic” article from The Journal of Bone & Joint Surgery. These articles have been selected by the Editor-in-Chief and Deputy Editors of The Journal because of their long-standing significance to the orthopaedic community and the many citations they receive in the literature. Our OrthoBuzz commentators will highlight the impact that these JBJS articles have had on the practice of orthopaedics. Please feel free to join the conversation about these classics by clicking on the “Leave a Comment” button in the box to the left.

The classic 1984 JBJS review of 520 cases of intramedullary (IM) nailing by Winquist, Hansen, and Clawson changed everything for patients with fractures of the femoral shaft.

In North America during the 1960s and 70s, the debate was all about details of traction management for femoral-shaft fractures: Balanced skeletal traction versus Perkins traction, where to place the traction pin, how many weeks until the spica cast and what type of spica cast, and whether a fracture brace was a viable option. At the same time in Europe, the Swiss orthopaedic community, which was the focal point for the AO, was advocating plate fixation to avoid “fracture disease,” pneumonia, and pulmonary emboli by mobilizing patients.

Meanwhile, Kay Clawson had traveled extensively in Europe and became aware of the outstanding results being achieved with closed, reamed, femoral nailing, as published (originally in German) by Gerhard Kuntscher.  Dr. Clawson ordered the equipment—including the reamers, intramedullary nails, and fracture table—and had them shipped to the University of Washington in Seattle.

There they sat on a pallet for more than a year until Dr. Clawson sent Bob Smith, one of the chief residents, to Europe to work with Kuntscher directly. Dr. Smith brought back the knowledge to do reamed IM nailing of the femur, and as experience increased, a Spokane farm boy turned orthopaedic resident named Ted Hansen became especially skilled at the procedure. When Dr. Hansen became an attending, he taught the procedure to another highly skilled resident, Bob Winquist.

Experience grew to the point where they were able to publish this classic manuscript with all its tips, tricks, and outcomes, including which fracture patterns could be treated without keeping patients in traction for weeks to maintain length, and which fractures required open cerclage to create length stability. During this time, there were no commercially available interlocking nails, so we developed ways to drill holes through Kuntscher rods and inserted cortical screws through them with free-hand technique. We also began retrograde nailing these fractures by increasing the bend of the rods to allow them to be inserted off the articular surface in the medial condyle.

This paper, which also carefully explains how procedures were refined as the authors’ experience grew from 1968 to 1979, ushered in the standard of care that exists today and spelled the end of traction treatment and plate fixation. It remains one of the most-cited articles in the history of musculoskeletal trauma literature.

Marc Swiontkowski, MD

JBJS Editor-in-Chief

JBJS Reviews Editor’s Choice–All About the Glenoid

The number of total shoulder arthroplasties performed in the United States has increased substantially in the past decade. In fact, since 2006, more total shoulder arthroplasties have been performed than hemiarthroplasties. Because of this surge in the number of total shoulder arthroplasties being performed, various techniques have been developed to address glenoid bone loss in patients with arthritic shoulder conditions. Indeed, primary glenoid bone loss usually occurs in association with osteoarthritis and is characterized by posterior wear patterns, whereas secondary glenoid bone loss usually occurs in association with trauma, glenoid loosening, and iatrogenic injury during revision surgery.

In the July 2015 issue of JBJS Reviews, Gowda et al. review a number of important issues related to this condition, including normal glenoid anatomy, pathological changes in glenoid substance, primary glenoid bone loss, proper imaging studies for the evaluation of the glenoid, principles of glenoid restoration, and the effects of poor implant position. Other topics, such as glenoid bone-grafting, the use of augmented components, glenoid insert design, patient-specific instrumentation, and the emergence of reverse total shoulder arthroplasty as an important component of the armamentarium of the shoulder arthroplasty surgeon, are also addressed.

The authors assert that proper preoperative imaging is critical in order to ascertain glenoid characteristics, including size, version, and depth of the vault. The treatment of glenoid bone loss is dependent on the degree of version correction that is required and consists of eccentric reaming, bone or polyethylene augmentation, and, as noted above, the potential use of reverse shoulder arthroplasty.

In the future, shoulder arthroplasty research should evaluate the long-term outcomes of biomaterial-augmented glenoid components, the use of other materials (such as ceramics), the utility of fixation within the glenoid and endosteal vault, and the use of reverse-polarity implants.

Thomas A. Einhorn, MD

Editor, JBJS Reviews

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

Culture of Patient Safety Lacking in Some Orthopaedic Environments

Eighteen percent of nearly 400 orthopaedic surgeons responding to an 89-question survey about patient safety said they do not perceive a positive climate for patient safety in their organizations. In the July 15, 2015 JBJS, authors Janssen et al. call that percentage “high when compared with the [10%] threshold for highly reliable organizations.” Perceptions of patient safety were higher among men, surgeons in non-teaching hospitals, and those working in hospitals with a safety program already in place.

The authors surmise that the perception of a better patient-safety climate in non-teaching hospitals may be attributable to less complex care requirements that permit “a more structured approach,” and to typically smaller institution sizes in which care providers are “more adapted to each other and work more as a team.”

The respondents said that orthopaedic surgeons themselves are mainly responsible for preventing wrong-site surgery and retained foreign bodies. The most commonly cited strategies for improving patient safety overall were:

  • Making safety everyone’s responsibility
  • Improving communication, and
  • Standardizing procedures, equipment, and supplies.

Interestingly, surgeons who received salaries not linked to procedure volume were more enthusiastic about safety programs than those who received fee-for-service compensation. Janssen et al. conclude that “knowledge of the variation in perceived safety and the enthusiasm for specific strategies to improve safety among surgeons can serve as a starting point for necessary cultural change.”

Bone Fracture-SSRI Link in Perimenopausal Women

The prescribing of selective serotonin reuptake inhibitors (SSRIs) for nonpsychiatric disorders has climbed steadily in recent years, and the June 2013 FDA approval of paroxetine to treat hot flashes associated with menopause is likely to expose more women to this popular class of antidepressants.

A new observational, claims-based analysis found that 137,000 women between the ages of 40 and 64 without mental illness who started an SSRI between 1998 and 2010 were 67% to 76% more likely to break a bone during the subsequent one to five years than 236,000 women of the same age who took indigestion drugs during the same time period. The analysis allowed for a six-month lag time to account for a presumed delay in the clinical effects of SSRIs on bone density. All told, the findings suggest that “shorter duration of treatment might mitigate the risk of developing excess fractures,” co-author Yi-han Sheu told MedPage Today.

Noting that the study did not account for varying dosages of SSRIs, Holly Puritz, MD, a spokesperson for the American College of Obstetricians and Gynecologists, told MedPage Today, “Overall fracture rates are extremely low in this age group, so noting an increase can look significant when discussed as a percentage, but [is] less meaningful when actual numbers are looked at.” And then there’s this possibly confounding factor: A study reported on in OrthoBuzz earlier this year found that hot flashes in and of themselves were associated with an increased risk of hip fractures in women.

CMS to Ease ICD-10 Rules for First 12 Months

The Centers for Medicare and Medicaid Services (CMS) announced this week that it will not deny claims from providers during the first 12 months of ICD-10 implementation based on a lack of code specificity, “as long as the physician/practitioner use[s] a valid code from the right family.” Similarly, CMS will not penalize physicians whose coding lacks ICD-10 specificity when reporting to the Physician Quality Reporting System, Meaningful Use, or Value Based Modifier programs, as long as the submitted code comes from the “correct family.”

In making this joint announcement with the AMA, CMS also said it will establish a “communication and collaboration center,” which will house an ombudsman “to help receive and triage physician and provider issues.” As “ICD-Day” (October 1, 2015) looms, CMS is encouraging small-practice providers to avail themselves of the readiness tools at the “Road to 10” website, which includes a separate section for orthopaedists.