Spine/Trauma 3D Navigation Software Recall
Brainlab AG is recalling its Spine & Trauma 3D Navigation software (version 1.0). The FDA has identified this as a Class I recall, the agency’s most serious category.
This navigation system provides images that help surgeons safely navigate instruments and implants used before and during minimally invasive surgeries. The software has been recalled because the displayed images may result in user misinterpretation and may prevent surgeons from accurately navigating surgical tools inside the patient.
Clavicle Fracture Research: Enough Already?
Orthopaedic surgeons and their staffs are aware of the paradigm shift that has taken place in the last 10 to 15 years regarding the treatment of clavicle fractures. Interest in the outcome differences between surgical and nonsurgical treatment has grown substantially since the 2007 Canadian Orthopaedic Trauma Society publication in JBJS showed that, relative to nonoperative treatment, plate fixation of displaced midshaft clavicle fractures resulted in improved functional outcomes and fewer malunions in active adult patients. Since that time, The Journal alone has published 14 articles related to management of clavicle fractures. In addition, the orthopaedic literature contains a number of well-conducted meta-analyses on the topic, comparing both nonoperative and surgical treatment as well as different methods of surgical fixation.
So, with all this evidence, why have we published the randomized controlled trial on this topic by King et al. in the April 3, 2019 issue of The Journal? Partly because the authors build upon our knowledge by comparing a relatively new fixation device (a flexible intramedullary locked nail) to a more standard treatment (an anatomically contoured plate). These plate and nail devices are very different from one another in terms of mechanics and surgical technique, and the flexible nail used in this study is much different than the rigid, straight nails or pins that have been used in the past.
A union rate of 100% was observed in both groups, but the authors found that the flexible nail was significantly faster in terms of operative time. (A single surgeon experienced with both devices performed all 72 surgeries.) They also found that the DASH scores between the groups were similar until the 12 month follow-up, at which point the flexible intramedullary nail group had statistically better scores. The authors concede, however, that the 12-month DASH-score difference “might not be clinically relevant.”
There is one other reason why we deemed this article important: The flexible intramedullary device used in this study is substantially more expensive than prior fixation devices that have been shown to effectively treat clavicular fractures. King et al. did not compare device costs, but whenever we study a device that adds to the total cost of care we should attempt to prove that it adds enough patient benefit to warrant the added expense. As the authors conclude, both devices evaluated in this study appear to be effective at treating displaced/shortened clavicular fractures, and there are a number of other factors that both the surgeon and patient should consider (such as surgeon skill and experience and cosmetic results) when deciding which treatment to use.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Preventing VTE in Below-the-Knee Surgery
Venous thromboembolism (VTE) following hip fractures and hip/knee arthroplasty—both deep vein thrombosis (DVT) and pulmonary embolism (PE)—has been relatively well studied. We therefore have a fairly clear understanding what the risks for DVT and PE are with no treatment as well as with modern preventive chemotherapeutic agents. However, such clarity on the need for and effectiveness of VTE prophylaxis is lacking for below-the-knee (BTK) orthopaedic procedures. This is largely due to the fact that such procedures have been deemed “low risk”—despite a dearth of supporting evidence for that assumption. In the March 20, 2019 issue of The Journal, Heijboer et al. used a sophisticated propensity score matching methodology to evaluate the rate of VTE in >10,000 BTK surgery patients at their tertiary care referral center.
The authors evaluated patients who underwent orthopaedic surgery distal to the proximal tibial articular surface, including foot/ankle procedures, open reduction of lower-leg fractures, and BTK amputations. They performed propensity score matching to compare 5,286 patients who received any type of chemotherapeutic prophylaxis with the same number who did not, across several key risk categories. The good news is that VTE prophylaxis effectively lowered the risk of symptomatic DVT or PE from 1.9% to 0.7% (odds ratio of 0.38, p <0.001).
Unfortunately (but not surprisingly), this effectiveness came at the price of increased systemic or local bleeding among patients using chemical VTE prophylaxis, with an incidence of 1.0% in the no-prophylaxis group and 2.2% in the prophylaxis group (odds ratio of 2.18, p <0.001). The authors did not assess the incidence of deep infection or hematoma formation, which often accompany increased local bleeding. The low overall incidence of VTE and bleeding did not allow for subgroup analysis according to location of surgery, and aspirin use was not controlled for in their study. In addition, Heijboer et al. used hospital coding data, and the accuracy of the database was not assessed.
The authors recommend that “anticoagulant prophylaxis be reserved only for patient groups who are deemed to be at high risk for VTE,” but we still don’t know precisely who is at high risk among BTK surgery patients. It is my hope that these findings will prompt large, prospective multicenter trials in the foot and ankle community to better determine which types of patients should be exposed to an increased risk of postoperative bleeding complications in order to achieve a clinically important decreased risk of VTE with chemical prophylaxis.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
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
PE Prevention—There’s an App for That
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Matthew Herring, MD in response to a recent study in the Journal of Orthopaedic Trauma.
Pulmonary embolism (PE) is a potentially life-threatening complication among many orthopaedic trauma patients. PE can be a silent killer, with only about 30% of fatal PEs being detected before death. Chemical prophylaxis with “blood thinners” such as injectable enoxaparin is effective in mitigating the risk of PE, but in the poly-traumatized patient, its application is often contraindicated. In an effort to develop a more effective approach to PE prevention in the trauma population, Starr et al. built a tool to estimate the risk of PE early and effectively, and then developed a multidisciplinary protocol for deep vein thrombosis (DVT) prophylaxis. They present their preliminary experience with the risk-assessment tool and the new protocol in the February 2019 issue of the Journal of Orthopaedic Trauma.
The smart-phone app (ParkLandOrtho) to risk-stratify trauma patients in the ED is based on 7 easily captured variables that the authors’ prior work identified as statistically significant predictors for developing a PE. Patients who are identified as “high risk” are aggressively started on enoxaparin, with the first dose ideally given prior to ED discharge. If contraindications for chemical prophylaxis are present, enoxaparin is withheld for up to 24 hours after admission. After 24 hours, if the patient is still unable to receive enoxaparin, a removable inferior vena cava (IVC) filter is placed.
The authors performed a retrospective review of PE incidence among 368 consecutive orthopaedic trauma patients admitted to their hospital after this new protocol was implemented and compared it to PE incidence among a historic cohort of 420 similar consecutive patients admitted during the year prior to the protocol. The two groups were similar in age and injury severity. In the control group, 51 patients were retrospectively classified as high risk, and 9 patients (2.1%) developed symptomatic PEs, one of which was fatal. In the group managed under the new protocol, 40 patients were identified as high risk, and only 1 patient (0.27%) developed a nonfatal PE. The difference in incidence of PE between the two groups was statistically significant (P = 0.02).
This paper highlights two significant achievements in my opinion. First, I was excited to see the success of a smart-phone app to facilitate rapid risk assessment. This was a significant key to the success of the multidisciplinary PE protocol, which depends on buy-in and compliance. Second, this thoughtful, decisive, and team-based protocol for DVT/PE prophylaxis in an orthopaedic trauma setting seems to be making a meaningful impact on patient outcomes.
The authors report that they are currently designing a multicenter trial to prospectively validate their protocol. I eagerly await this and hope that their next step includes a ParklandOrtho app release for Android devices, as it is only available now for iPhone and Samsung users.
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.
Are We Overprescribing Opiates to Some Pediatric Patients?
How much opioid analgesia do pediatric patients need after closed reduction and percutaneous pinning of a supracondylar humeral fracture? Not as much as they are being prescribed, suggests a study of 81 kids (mean age of 6 years) by Nelson et al. in the January 16, 2019 issue of The Journal of Bone & Joint Surgery.
All patients in the study underwent closed reduction and percutaneous pinning at a single pediatric trauma center. The authors collected opioid utilization data and pain scores (using the Wong-Baker FACES scale) for postoperative days 1 to 7, 10, 14, and 21 via a text-message system, with automated text queries sent to the phones of the parents/guardians of the patients. (Click here for another January 16, 2019 JBJS study that relied on text messaging.)
Not surprisingly, the mean postoperative pain ratings were highest on the morning of postoperative day 1, but even those were only 3.5 out of a possible 10. By postop day 3, the mean pain rating decreased to <2. As you’d expect, postoperative opioid use decreased in parallel to reported pain.
Overall, patients used only 24% of the opioids they were prescribed after surgery. (See related OrthoBuzz post about the discrepancy between opioids prescribed and their actual use by patients.) Considering that pain levels and opioid usage decreased in this patient population to clinically unimportant levels by postoperative day 3, the authors conclude that “opioid prescriptions containing only 7 doses would be sufficient for the majority of [pediatric] patients after closed reduction and percutaneous pinning without compromising analgesia.”
Now that some normative data such as these are available, Nelson et al. “encourage orthopaedic surgeons treating these common [pediatric] injuries to reflect on their opioid-prescribing practices.” They also call for prospective randomized studies into whether non-narcotic analgesia might be as effective as opioid analgesia for these patients.
Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients
Background: Elderly patients with a displaced femoral neck fracture treated with hip arthroplasty may have better function than those treated with internal fixation. We hypothesized that hemiarthroplasty would be superior to screw fixation with regard to hip function, mobility, pain, quality of life, and the risk of a reoperation in elderly patients with a nondisplaced femoral neck fracture.
Nondisplaced Femoral Neck Fractures in the Elderly: Minimizing Complications
Trying to educate elderly patients and their family members about how to best treat a femoral neck fracture can be difficult. These patients typically have multiple—and often severe—medical comorbidities that can make even the most “simple” surgery complex and life-threatening. Making such discussions even harder is the lack of Level-I evidence related to treating these common injuries. For severely displaced fractures, the evidence supports performing either a hemi- or total hip arthroplasty on most patients. But the data is much less clear for minimally or nondisplaced fractures.
For these reasons, I was excited to read the study by Dolatowski et al. in the January 16, 2019 issue of JBJS. The authors performed a prospective, randomized controlled trial comparing internal screw fixation to hemiarthroplasty for valgus impacted or nondisplaced femoral neck fractures in >200 patients with a mean age of 83 years. They found that patients who underwent hemiarthroplasty had a significantly faster “up-and-go” test and were significantly less likely to undergo a major reoperation than those who underwent internal fixation. However, patients in the internal-fixation group were less likely to develop pulmonary complications. There were no between-group differences in overall hip function (as evaluated with the Harris hip score) or in the 24-month mortality rate.
This study lends support to what many surgeons tell elderly patients with a nondisplaced femoral neck fracture: a hemi- (or total) arthroplasty will probably provide the lowest risk of needing a repeat operation for the injury, while placing percutaneous screws may decrease the risk of cardiopulmonary complications related to the operation. While these findings may not be surprising, this study provides important Level I data that can help us educate patients and their families so that the best treatment for each individual patient can be determined.
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
Self-Reported Marijuana Use Is Associated with Increased Use of Prescription Opioids Following Traumatic Musculoskeletal Injury
Full Article
Cannabinoids are among the psychoactive substances considered as alternatives to opioids for the alleviation of acute pain. We examined whether self-reported marijuana use was associated with decreased use of prescription opioids following traumatic musculoskeletal injury.
Complications Following Overlapping Orthopaedic Procedures at an Ambulatory Surgery Center
Full Article
Overlapping surgery occurs when a single surgeon is the primary surgeon for >1 patient in separate operating rooms simultaneously. The surgeon is present for the critical portions of each patient’s operation although not present for the entirety of the case. While overlapping surgery has been widely utilized across surgical subspecialties, few large studies have compared the safety of overlapping and nonoverlapping orthopaedic surgery.
Recent Comments