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Pediatric Limb-Lengthening: A Cautionary Tale

JBJS Editor-in-Chief Dr. Marc Swiontkowski brought to OrthoBuzz’s attention a recent “Family Partnerships” essay published in Pediatrics. The 4 “speakers” in the essay chronicle the suffering and pain of Lindsay Ellingworth, who was born with a congenital lower-limb deficiency. Lindsay’s young parents opted for limb lengthening over amputation plus a prosthesis after several orthopaedic consultations and an agonizing, confusing decision-making process.

Orthopaedic surgeon Dr. David Hootnick entered the picture about 10 years ago, when he first saw Lindsay, who was by then a young nursing student with ongoing problems associated with the index procedure—including scoliosis and chronic neck and back pain. The extent of the original deformity (30% femur shortening at birth) made Lindsay a “nonideal candidate for lengthening,” says Dr. Hootnick, but he adds that “Lindsay had a normal-appearing foot, making it all the more understandable that her parents balked at removing an apparently healthy part of their beloved child.”

Lindsay describes her limb-lengthening and years of treatments for complications as “a living nightmare.” Now an adult, she has concluded that “the doctors put a pretty bow on limb lengthening.” Pediatrician and bioethicist Dr. Amy Caruso Brown acknowledges in the essay the untenable bind Lindsay’s parents found themselves in when having to make a decision before their child was old enough to express preferences. “It is difficult to accept that a procedure that sounds as drastic and anachronistic as amputation might have fewer complications than the seemingly more sophisticated alternative,” Dr. Brown said.

According to Lindsay’s mother Rene Mauchin, “Although she has endured so much, Lindsay still laughs and celebrates life.” When asked for a takeaway that might help other families in similar situations, Ms. Mauchin said, “You have a right to know everything the doctors know…Don’t hesitate to see several doctors, and ask for evidence to back up their recommendations.”

When Does I&D Beat 2-Stage Exchange in Second rTKA?

It’s hard to contemplate “conservative treatment” in the case of a revised total knee arthroplasty (rTKA) with extensive instrumentation that needs a reoperation due to periprosthetic joint infection (PJI), because all the treatment options in that scenario are pretty complex. In the January 6, 2021 issue of JBJS, Barry et al. report on a retrospective review of 87 revisions of extensively instrumented rTKAs that found that irrigation and debridement (I&D) with chronic antibiotic suppression was as effective as 2-stage exchange in preventing another reoperation for infection—and more effective in terms of maintaining knee function.

The average follow-up of the cases studied was 3.2 years, and the authors carefully defined “extensive instrumentation.” Among the 56 patients who were managed with I&D and suppression and the 31 who were managed with the initiation of 2-stage exchange (average age in both groups approximately 67 years), no significant differences were found in the rates of reoperation for infection or mortality. However, 9 of the 31 patients (29%) in the 2-stage group never underwent the second-stage reimplantation. Among those 9, 3 died prior to reimplantation and 2 underwent amputation due to failure of infection control.

Moreover, at the time of the latest follow-up, a significantly higher percentage of patients in the I&D group were ambulatory (76.8% vs 54.8% in the 2-stage group) and were able to functionally bend their knee (85.7% vs 45.2% in the 2-stage group). The authors surmise that these 2 findings are related to the soft-tissue damage and bone loss that typically occur during stage-1 removal of rTKA components.

Barry et al. conclude that in similar situations “deviating from the so-called gold standard of 2-stage exchange and accepting the modest results of I&D may be in the best interest of the patient,” as long as there are no loose implants in the existing construct. But the “sobering” mortality rates in the study (39.3% in the I&D group and 38.7% in the 2-stage group) remind us that this clinical scenario is extremely challenging for patients and surgeons, no matter which option is selected.

Click here to view an “Author Insights” video about this study with co-author Jeffrey Barry, MD.

FDA OKs Synthetic Implant for Repairing ACL Tears

OrthoBuzz has been following the development of the Bridge-Enhanced ACL Repair (BEAR) implant—a synthetic alternative to graft-based anterior cruciate ligament reconstruction—since 2015 (see previous OrthoBuzz posts). On December 16, 2020 the FDA granted authorization to Miach Orthopaedics, Inc. to market the implant.

The BEAR implant is made from bovine collagen. After securing it with sutures to the torn ends of a completely ruptured ACL, the surgeon injects the patient’s own blood into the implant, which forms a clot that enhances ligament healing. Within 8 weeks, the implant is resorbed and replaced by the body’s own tissue.

The FDA’s authorization was based on results from a 100-patient randomized clinical trial, in which 65 patients received the BEAR implant and 35 underwent conventional autograft reconstruction. After 2 years, patient-reported outcomes in both groups were similar for pain, knee function, and sports activity, and arthrometry showed nearly identical joint-laxity outcomes. It remains to be seen how durable the BEAR implant will be over time and how much arthritis will develop in BEAR-treated knees 15 or 20 years from now.

The FDA’s marketing authorization for the BEAR implant was granted under the agency’s de novo device review pathway. That means that subsequent similar devices can be reviewed through the FDA’s 510(k) process, which requires a demonstration of “substantial equivalence” to the predicate device.

A Deeper Dive into Diabetes and Total Joint Replacement

There are many more “types” of diabetes than the pathophysiologic designations of Type 1 and Type 2. In the December 16, 2020 issue of The Journal of Bone & Joint Surgery, Na et al. delineate 4 different diabetes categories and determine their impact on 90-day complications and readmission rates after elective total joint arthroplasty (TJA) among Medicare patients. One premise for this investigation was that, although diabetes is a known risk factor for arthroplasty complications, alternative payment models such as the federally run Comprehensive Care for Joint Replacement (CJR) program adjust their payments only in diabetes cases where the comorbidity is coded as severe.

The authors stratified diabetes into 4 groups as follows:

  1. No diabetes
  2. Controlled-uncomplicated diabetes
  3. Controlled-complicated diabetes
  4. Uncontrolled diabetes

Among the >500,000 total knee arthroplasties (TKAs) and total hip arthroplasties (THAs) analyzed, the authors found the following when comparing data from the 3 diabetes groups with the no-diabetes group:

  • The odds of TKA complications were significantly higher for those with uncontrolled diabetes (odds ratio [OR] = 1.29).
  • The odds of THA complications were significantly higher for those with controlled-complicated diabetes (OR = 1.45).
  • The odds of readmission were significantly higher in all diabetes groups for both TKA (ORs = 1.21 to 1.48) and THA (ORs = 1.20 to 1.70).

The authors come to 3 basic conclusions based on these findings:

  1. The odds of hospital readmission and complications following an elective TKA or THA are increased for Medicare beneficiaries who have diabetes.
  2. It would be reasonable to defer arthroplasty surgery for those with uncontrolled diabetes to allow them to achieve glycemic control.
  3. The Centers for Medicare & Medicaid Services should include less-severe diabetes and associated systemic complications in alternative-payment model adjustments.

Click here for an “Author Insight” video about this study from co-author Annalisa Na, PhD, DPT.

Eschew Standard-Sized Heads When Revising THAs for Dislocation

No consensus has emerged yet regarding the best prosthetic construct with which to manage patients who require revision surgery for dislocation after a total hip arthroplasty (THA). But in the December 2, 2020 issue of The Journal of Bone & Joint Surgery, Hoskins et al. add insight into that question by tapping the Australian Orthopaedic Association Total Joint Replacement Registry to analyze which of 4 first-revision component constructs led to the fewest second revisions.

Among the 1,275 THAs that were revised once for prosthesis dislocation, 203 hips went on to have a second revision, with dislocation being the most common cause for re-revision. The authors studied the second-revision THAs in 4 prosthetic categories: standard-sized femoral heads, large-sized femoral heads, dual-mobility heads, and constrained acetabular liners. The rate of all-cause second revision was significantly higher in the standard-head group when compared with the constrained-liner group. But in the 91 cases of second revisions for dislocation, the standard head showed significantly higher second-revision rates than any of the other 3 constructs. There was no statistically significant difference in rates of second revision between those 3 non-standard articulations

The authors discuss dual-mobility heads at some length, asserting that “caution should be exercised in their routine use, particularly in younger and active patients.” They note that the constrained liner was the “only articulation to show a difference when compared with standard-head THA for both all-cause revision and revision for a subsequent diagnosis of dislocation,” but they observe that impingement and acetabular component loosening are common concerns with constrained liners.

Despite these caveats, it seems clear from this data that the choice of articulating surface for either a first or second revision THA due to dislocation should probably exclude standard head sizes. Calling for longer-term data on all 3 alternative constructs studied here (the follow-up periods were different for all 4 articulations), the authors emphasize that “surgeons should [also] look beyond articulating surfaces”—to surgical approach, component orientation, and patient factors such as soft-tissue quality—in the effort to reduce the burden of THA dislocations.

Big Data Needs Big Progress

This post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.

The broad term “big data,” when applied to health care, refers to the mining of large databases to find information that might predict and improve clinical outcomes on a national scale. A recent article in AAOSNow cites one example of the merging of big data with artificial intelligence (AI) as the 10-year partnership between the Mayo Clinic and Google to leverage cloud technologies, machine learning, and AI to accelerate change in healthcare delivery. The American Joint Replacement Registry (AJRR) is also using big data to help hospitals make more efficient supply-chain decisions and lower costs.

However, there are limitations and potential flaws in the use of big data. One is the high cost, making it unaffordable for some institutions. In addition, variations in how the data is collected and reported may lead to flawed analyses. Also, data collection may vary in completeness by region, which makes nationwide registries with consistent data collection so important. Big data can also be contaminated by bias. Even large datasets may over- or underrepresent certain groups of people, thereby skewing any analysis made with those data.

There are several solutions to improve the use of big data in orthopaedics. One is the development of registries with uniform and consistent data collection methods to ensure equity. Participation in registries by orthopaedic surgeons is critical. The authors of the AAOSNow article also emphasize that if patient data were linked longitudinally, researchers would have a powerful tool with which to study health outcomes and monitor public health trends. However, current HIPAA rules prevent clearinghouses from linking data that way. To update the law to match our data-driven reality, in 2017 US Rep. Cathy McMorris Rodgers (D-Ore.) introduced the Ensuring Patient Access to Health Records Act (H.R. 4613), which would allow greater access to big data for the purpose of research, public health, and personal patient use. The bill has been tied up in committee since December 15, 2017. The ultimate objective of using big data in medicine is to provide health care that is “predictive, preventive, personalized, and participatory,” conclude the authors.

How Much Radiation Does a Surgeon’s Brain Receive during Femoral Nailing?

OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Impact Science, in response to a recent article in JBJS.

Surgeon exposure to ionizing radiation during C-arm fluoroscopy is common during many orthopaedic procedures, including fracture reduction and fixation-implant positioning. With increased exposure, concern about potential health risks to staff also increases.

A new study in the November 18, 2020 issue of The Journal of Bone & Joint Surgery estimates how much radiation a surgeon’s brain is exposed to while performing short cephalomedullary (SC) nailing over a 40-year career. Ramoutar et al. used two cadaveric specimens (one representing the patient and one head-and-neck specimen representing the surgeon) during a simulated fluoroscopic-guided femoral-nailing procedure.

The dose of radiation to the brain was measured with sensors implanted in the cadaver brain and placed superficially on the skull. Measurements were made with the surgeon specimen set up with different configurations of personal protective equipment (PPE) to test their effectiveness at shielding the brain from radiation.

Ramoutar et al. calculated that the overall extrapolated lifetime dose over 40 working years for surgeons performing 16 SC nailing cases per year without PPE was 2,146 µGy, which is comparable to the radiation exposure during a 1-way flight from London to New York. The authors also found that the use of a thyroid shield was very effective in reducing the radiation exposure to the brain, although the use of additional PPE (e.g., leaded glasses and lead cap) did not add any significant reduction in brain exposure to radiation.

In addition to concluding that the lifetime brain dose of radiation from SC nailing is low, the authors say the findings should encourage surgeons performing this procedure to use thyroid shields. This study also provides a repeatable methodology for future studies investigating brain-radiation doses during other common orthopaedic procedures.

Impact Science is a team of highly specialized subject-area experts (Life Sciences, Physical Sciences, Medicine & Humanities), who collaborate with authors, societies, libraries, universities, and various other stakeholders for services to enhance research impact. Through research engagement and science communication, Impact Science aims at democratizing science by making research-backed content accessible to the world.

 

RCT: “Mini-Navigation” Improves TKA Component Alignment

Alignment is one of the most important factors affecting the longevity of total knee arthroplasty (TKA) prostheses. Among the many available tools for attaining good alignment are new palm-sized, accelerometer-based navigation systems. In the November 18, 2020 issue of The Journal of Bone & Joint Surgery, Minoda et al. deliver robust evidence from a multicenter randomized controlled trial comparing post-TKA coronal alignment with such a “mini-navigation” system versus results using conventional navigation.

The 90 TKAs analyzed (45 in each group) were performed by 8 different surgeons across 5 hospitals in Japan. The primary outcome was the number of tibial-prosthesis alignment outliers, defined as alignment error of >2° relative to neutral, based on weight-bearing radiographs 6 months after surgery. Researchers also compared absolute differences from neutral alignment for both tibial and femoral components, operative time, and complications.

Relative to conventional navigation, the mini-navigation system reduced the number of outliers in tibial alignment and hip-knee-ankle (HKA) angle. In addition, the absolute differences in the coronal alignment of the femoral and tibial prostheses were less in the mini-navigation group. Researchers found no increase in operative time with the portable navigation system, nor was there any observed increase in perioperative complications compared with conventional navigation.

Conversely, there were no significant between-group differences in postoperative Knee Society scores, but the authors note that “another study design with a longer follow-up period” is needed to evaluate the patient-centered clinical effects of prosthetic alignment using portable navigation. Both the authors and Andrew P. Kurmis, FRACS(Ortho), who commented on the study, assert that the true value of navigation systems (mini and full-sized alike) probably lies in higher reproducibility of tibial-component alignment relative to conventional navigation, regardless of the skill and experience of the surgeon.

Dashboard Depicts Surgeon-Level Value of TKA/THA

Remember when a “dashboard” referred to the display just behind a car’s steering wheel? In today’s digital universe, the word has come to mean any number of visual information displays. At the same time, the meaning of the word “value” has narrowed somewhat. In relation to health care, “value” is defined quite precisely as the quality of patient outcomes per dollar spent on healthcare services.

In the November 4, 2020 issue of The Journal of Bone & Joint Surgery, Reilly et al. explain how they created a “value dashboard” for total hip and knee arthroplasty (THA and TKA) at a tertiary-care medical center in New England. The goal: track and display the surgeon-level cost and quality of these procedures against institutional benchmarks to identify opportunities for improving value.

The 7 quality metrics that Reilly et al. used included both clinical and patient-reported outcomes, weighted by surgeons using a modified Delphi process. Average direct costs per surgeon were calculated from the medical center’s billing system, and data were collected over a 15-month period from 2017 to 2018 to ensure at least 1 year of outcomes. Six surgeons were included in the TKA value dashboard, and 5 were included in the THA dashboard.

Relative to the institutional benchmarks:

  • Value for TKA by surgeon ranged from 7% below benchmark to 12% above.
  • Value for THA by surgeon ranged from 12% below benchmark to 7% above.

The dashboard itself (see Figure above) displays quality, cost, and overall value so viewers can see at a glance which metrics are driving the value score for each surgeon, whose procedural volume is also depicted. The authors cite as one limitation of this study the fact that the quality metrics were weighted by local surgeons only, and they say that “ideally the weighting would be informed by a panel of national experts and several stakeholder groups,… including patients.”

History Counts–And It Needs to Be Complete

Joel L. Boyd, MD

It has often been shown that those who do not study history are doomed to repeat its mistakes. The Journal of Bone & Joint Surgery has a >130-year history, which we must continue to review. Understanding our history is so important that JBJS staff and trustees have invested in a 6-month project to get our history encapsulated and published on our website for continuous reference and reflection. The history of our journal contains mistakes—one stark example of which is promulgating the use of metal-on-metal arthroplasty.

But history is not complete until all the stories are told. Incomplete history is particularly evident with our North American native populations and individuals of African heritage. Here history is recorded with formerly conscious and now primarily unconscious (I hope) bias against accurately detailing the important contributions of native and Black citizens.

In the November 4, 2020 issue of The Journal, Dr. Joel Boyd does us great service by setting the record straight regarding the contributions of Black Canadians and Americans to the sport of ice hockey. (Our collective history in orthopaedics has particular relevance in sports.) Black athletes were on the ice at the sport’s very inception and in the early formation of competitive leagues. Dr. Boyd’s history, which focuses on the Black Hockey League of the Maritimes and  Willie O’Ree, the “Jackie Robinson of hockey,” is replete with bias against acknowledging these contributions and against allowing non-Whites to compete for the sport’s highest trophies.

Let us all study these contributions, recognize their importance, and vow to be ever-vigilant for any bias, conscious or unconscious, in our thinking and conduct. May Dr. Boyd’s important exercise in completing this bit of history repeat itself in sport, science, and medicine across the board.

Marc Swiontkowski, MD
JBJS Editor-in-Chief