“First do no harm.” Patients undergo operative procedures with the inherent belief that their surgeon will perform the operation in a safe and effective manner, and, certainly, on the correct organ or body part. However, recent data suggest that in orthopaedic surgery alone, 21% of hand surgeons, 50% of spine surgeons, and 8.3% of knee surgeons have performed wrong-site surgery at least once during their career. These are astonishing numbers! Orthopaedic surgeons are at increased risk of performing wrong-site surgery, mainly because of the inherent nature of the musculoskeletal system. Anatomic factors such as laterality, multiple digits, and different spinal levels predispose to wrong-site surgery. Despite the importance of this problem, the incidence of wrong-site surgery in orthopaedics is unknown, primarily because of the lack of data regarding the exact numbers of operative procedures performed.
In this month’s issue of JBJS Reviews, Santiesteban et al. reviewed wrong-site surgery and the history of the development of procedures and practices to avoid it in orthopaedic surgery. Their research shows that, in 1994, the Canadian Orthopaedic Association was the first orthopaedic organization to introduce a surgical safety program designed to reduce wrong-site surgery, known as “Operate Through Your Initials.” Soon thereafter, in 1997, the American Academy of Orthopaedic Surgeons (AAOS) appointed a task force on wrong-site surgery, and, in 1998, the AAOS introduced “Sign Your Site,” a national surgical safety campaign distributed to all hospitals in the United States. By 2004, The Joint Commission became involved and introduced the Universal Protocol, requiring its use for Joint Commission recertification. This protocol recommends the use of three standardized preoperative safety components for every surgical procedure by every surgical team: (1) proper patient identification, (2) marking of the surgical site, and (3) use of a time-out procedure prior to the incision. Wrong-site surgery is preventable, as this initiative was meant to show.
It remains unclear how effective the various adopted methods (including improved consent procedures between the physician and patient, preoperative signing of the appropriate surgical site, time-out protocols, and postoperative debriefings) have been at decreasing the rate of wrong-site surgery. Indeed, it was more than a decade ago that the development of new protocols designed to prevent wrong-site surgery were implemented. Although these protocols have been adopted in most operating rooms, wrong-site surgery and adverse events continue to occur on a weekly basis.
Wrong-site surgery remains a rare but preventable catastrophic surgical event. As noted, the true incidence is unknown. As many as one in four orthopaedic surgeons will perform wrong-site surgery during an active twenty-five-year surgical career, and orthopaedic spine surgeons appear to be at highest risk. Surgeon leadership, commitment, and vigilance are critical to improve surgical patient safety. By adopting these initiatives, wrong-site surgery can be prevented.
Thomas Einhorn, MD
Editor, JBJS Reviews
Meaningful use (MU) Stage 2 and 3 requirements have been a bane of existence for many physician practices, so a collective sigh of relief was heard when acting CMS administrator Andy Slavitt hinted recently that a more streamlined approach to regulating health care IT is coming.
Suggesting that MU as we know it may end altogether sometime in 2016, Slavitt offered few specifics in a speech at the recent JP Morgan Healthcare Conference, saying only that details of the new plan will come out “over the next few months.”
Beth Israel Deaconess Medical Center CIO John Halamka, MD, a frequent blogger on the subject of meaningful use, has said more than once that Stages 2 and 3 tried to do too much too fast, while lauding the functional foundation established by Stage 1. Halamka noted that when MU requirements are heaped on other rules and regulations such as HIPAA, the ACA, ICD-10, and Medicare value-based payment systems, the entire game becomes too complicated and confusing for everyone, including government auditors.
On January 14, 2016, 31 healthcare organizations (including notables such as Geisinger, Intermountain, and Partners) sent a letter to HHS secretary Sylvia Burwell, urging her to “restructure the MU program to fit future care needs and focus on improving interoperability and usability” of EHRs.
Stay tuned…OrthoBuzz will keep you posted.
We posted our first “Case Connections” article about bisphosphonate-related atypical femoral fractures (AFFs) one year ago. Since then, JBJS Case Connector has published three additional case reports on the same topic, suggesting that it’s time for a revisit. These three recent cases demonstrate that AFFs can occur despite prophylactic intramedullary (IM) nailing of an at-risk femur, that AFFs can present as periprosthetic fractures, and that men taking bisphosphonates—not just women—can experience AFFs.
The two numbers that you’ll want to remember from the computer model-based cost-effectiveness study by McLawhorn et al. in the January 20, 2016 Journal of Bone & Joint Surgery are $13,910 and $100,000. The first number is an incremental cost-effectiveness ratio (ICER). Here, it’s the estimated added cost per quality-adjusted life year (QALY) for morbidly obese patients (BMI ≥35 kg/m2) with end-stage knee osteoarthritis who undergo bariatric surgery two years prior to total knee arthroplasty (TKA), compared with similar patients who undergo immediate TKA.
The $100,000 is the threshold “willingness to pay” (WTP) that the authors used in their evaluation. Willingness to pay reflects the amount society and healthcare payers such as Medicare and private insurers are willing to pay for a patient to accrue one year lived in perfect health.
Here’s another way to view these findings: Morbidly obese patients who undergo TKA are at increased risk for wound-healing problems, superficial and deep infections, early revision, and poor function. The authors estimated that if bariatric surgery reduces the TKA risks in these patients by at least 16%, on average, the combination of bariatric surgery followed by TKA is more cost-effective than immediate TKA alone.
Because the ICER was much less than the WTP in this model, the authors conclude that “bariatric surgery prior to total knee arthroplasty may be a cost-effective option for improving outcomes in motivated patients with a BMI of ≥35 kg/m2 with end-stage knee osteoarthritis.” However, they are quick to add that “decision modeling cannot simulate reality for every clinical situation.” While this rigorously developed model may provide a decision-making framework for surgeons and policymakers, the authors say, “this approach may be impractical for an individual patient…desiring immediate symptomatic relief from knee osteoarthritis.”
In the January 20, 2016 JBJS prognostic study by Gornet et al., patients with Workers’ Compensation (WC) insurance coverage were compared to a group not covered by that insurance mechanism in regard to outcomes after cervical disc arthroplasty. Multiple studies have been published looking at WC coverage in relation to outcomes after many orthopaedic interventions, including spinal disease, fractures, and soft tissue injuries. The findings have generally identified worse outcomes in terms of pain relief, return to work, and function among WC-covered cohorts.
That was not the case in this analysis by Gornet et al. Only the number of days off before returning to work was different (significantly higher) for WC patients. There were no significant between-group differences in patient-reported outcomes, reoperation rates, complications, or the proportion of patients who returned to work.
I think we can gain some insight into the generally poorer reported outcomes for WC patients by considering that patients with higher functional demand employment experience greater stressors on their musculoskeletal systems. They also often have lower levels of education, which in turn can translate into less control over the work environment. I believe that it is the combination of these two factors that lead some WC patients to emphasize their pain symptoms and functional disability.
Rather than look askance at patients with WC coverage, I think we need to factor in these physical and work-disempowerment issues into our decision making and recommendations. If we do that, we might go beyond making sound clinical recommendations to suggest job retraining or additional classroom education so that the mechanical loads can be lessened and more empowerment at work can be obtained.
Marc Swiontkowski, MD
The International Association for the Study of Pain (IASP) recently launched its 2016 “Global Year Against Pain in the Joints.” In addition to disseminating clinical information focused on joint pain, the campaign seeks to:
- Connect pain researchers to other health care professionals who interact with joint-pain patients
- Increase public and governmental awareness of joint pain, and
- Encourage funders to support research aimed at producing more effective and accessible treatments for people with joint pain.
The Global Year Against Pain in the Joints website includes links to joint pain-related articles from the IASP’s journal Pain and the organization’s six-times-a-year publication Pain: Clinical Updates. An interview with campaign co-chairs Lars Arendt-Nielsen and Serge Perrot points to promising pain-management research with monoclonal antibodies and biologics directed at anti-nerve growth factor (anti-NGF).
Claiming that “up to 20 percent of joint pain patients do not achieve pain relief after joint replacement,” Dr. Arendt-Nielsen stressed the importance of “partnering with other influential individuals and groups outside of the [IASP]” to achieve the campaign’s goals.
Intraoperative injury to the medial collateral ligament (MCL) is a rare but important complication of total knee arthroplasty (TKA). Surgeons face two basic choices when it happens: intraoperatively converting to a more constrained TKA prosthesis, or primary repair of the MCL followed by protective bracing.
The retrospective review by Bohl et al. in the January 6, 2016 edition of The Journal of Bone & Joint Surgery does not compare those options head-to-head, but with an average follow-up of more than 8 years, it provides solid evidence that intraoperative repair followed by bracing is a successful long-term strategy.
The authors followed 45 TKAs that sustained either an intraoperative midsubstance MCL tear or an avulsion; 35 injuries occurred during a cruciate-retaining procedure, and 10 during a posterior-stabilized TKA. At a mean final follow-up of 99 months:
- There were no symptoms on physical examination of coronal-plane instability
- All patients were capable of community ambulation without an assistive device, and
- The mean HSS knee score had increased from 47 preoperatively to 85.
Five knees (11%) required intervention for stiffness. Although the authors emphasize that “in all cases the brace was set to allow full range of motion of the knee,” bracing may nevertheless have promoted stiffness by inhibiting range of motion in a cohort that included large proportions of obese and morbidly obese patients. This particular finding suggests that range-of-motion exercises should be emphasized after similar surgeries.
Whenever the impact of surgeon volume on patient outcomes for technically complex interventions has been assessed, the following correlation has held: the higher the surgeon volume, the better the patient outcomes. Working with us at the University of Washington in 1997, Dr. Hans Kreder was one of the first to observe this relationship in joint replacement surgery.1 Patients whose hip replacement was performed by a “high-volume” surgeon (>10 hip replacements per year) were significantly less likely to die or have an infection or revision than those whose procedure was performed by a “low-volume” surgeon (<2 hip replacements per year). This makes perfect intuitive sense—the more you do something, the better your skill, and the better the result.
In the study by Liddle et al. in the January 6, 2016 JBJS, the same volume-outcome relationship for knee arthroplasty is confirmed. The relationship is stronger for unicompartmental arthroplasty than it is for total knee arthroplasty (TKA). Again this makes intuitive sense because the “uni” procedure is more dependent on nuanced bone cuts and component placement than TKA, which relies more heavily on the use of guides and jigs.
Does this mean that the end of general orthopaedic surgeons performing joint replacement is at hand? I don’t think so. Many patients will prefer to stay in their community rather than travel to the high-volume surgeon/hospital even after being informed of the volume-outcome relationship. Additionally, joint registries and routine measurement tools now exist that can help lower-volume surgeons monitor their patient outcomes and demonstrate that their results are similar to those of higher-volume surgeons.
Ultimately, all surgeons are responsible for assessing their individual patient outcomes and making that data available for patients who are considering joint arthroplasty.
Marc Swiontkowski, MD
- Kreder HJ, Deyo RA, Koepsell T, Swiontkowski MF, Kreuter W. Relationship between the volume of total hip replacements performed by providers and the rates of postoperative complications in the state of Washington. J Bone Joint Surg [Am] 1997;79(4):485-94.
All you stats geeks out there will love the January 6, 2016 study in The Journal of Bone & Joint Surgery by Schilling and Bozic. We at OrthoBuzz are going to skip the gory statistical details for the most part and focus on the essential findings.
First the premise and purpose of the study: Because measuring and improving health care outcomes are nowadays top priorities, risk adjustment—methods to account for differences in patient characteristics across providers—has become a contentious issue. General risk-assessment models tend not to be well-tailored to orthopaedic procedures. So Schilling and Bozic developed a series of risk-adjustment models specific to 30-day morbidity and mortality following hip fracture repair (HFR), total hip arthroplasty (THA), and total knee arthroplasty (TKA). To develop their models, they used prospectively collected clinical data from the National Surgical Quality Improvement Program.
Here are the major findings: For THA and TKA, risk-adjustment models using age, sex, and American Society of Anesthesiologists (ASA) physical status classification were nearly as predictive as models using many additional covariates. HFR model discrimination improved with the addition of comorbidities and laboratory values. Vital signs did not improve model discrimination for any of the procedures.
The study confirms that it is possible to provide adequate risk adjustment for analyzing outcomes of these procedures using only a handful of the most predictive variables commonly available within the operative record. “More parsimonious models are a viable alternative when the adequacy of risk adjustment must be weighed against the cost and burden of large-scale data extraction from the clinical record,” the authors conclude.