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.
In Chronic Sciatica, Gabapentin Quells Nerve Pain Better than Pregabalin
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.
Orthopaedic surgeons may not be at the forefront of dealing with nonoperative nerve pain, but many of our patients who are not candidates for surgery suffer from spine-related nerve pain in their limbs, such as sciatica. Both gabapentin (GBP, Neurontin) and pregabalin (PGB, Lyrica) are used to treat chronic sciatica (CS).
Gamma-aminobutyric acid (GABA) is an important pain-related neurotransmitter, although neither GBP nor PGB affect the GABA receptor. Instead, both drugs associate with the ligand of the auxiliary α2δ-1 and α2δ-2 subunits of certain voltage-dependent calcium channels in nerves. Among other uses, Neurontin is prescribed to treat diabetic peripheral neuropathy, and Lyrica is commonly used to treat fibromyalgia.
Investigators reporting in JAMA Neurology sought to help guide practitioners in the initial choice of drug. Eighteen patients with MRIs corroborating single-sided nerve-root sciatic pain of at least 3 months duration were evaluated in an interim analysis as part of a randomized, double-blind, double-dummy crossover trial of PGB vs GBP (8 weeks of exposure to each drug with a 1-week washout in between). The primary outcome was pain intensity measured with a 10-point visual analog scale (VAS) at baseline and 8 weeks. Secondary outcomes included disability as measured with the Oswestry Disability Index and the severity and frequency of adverse events.
Relative to baseline, both drugs showed significant VAS pain reductions and disability-score improvements, However, head-to-head, GBP showed superior VAS pain reduction (mean [SD], GBP: 1.72 [1.17] vs PGB: 0.94 [1.09]; P = 0.035), regardless of the order in which it was given. There were no between-drug differences in disability scores, but adverse events for PGB were more frequent (PGB, 31 [81%] vs GBP, 7 [19%]; P = 0.002), especially when PGB was taken first.
The authors conclude that GBP was superior with fewer and less severe adverse events, and they suggest that gabapentin should be commenced before PGB to permit optimal crossover of medicines.
Reference
Robertson K, Marshman LAG, Plummer D, Downs E. Effect of Gabapentin vs Pregabalin on Pain Intensity in Adults WIth Chronic Sciatica: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 15. doi: 10.1001/jamaneurol.2018.3077. [Epub ahead of print] PMID: 30326006
Questionnaire Helps Identify Lumbar Patients Who Need Surgeon Consult
Only about 10% to 15% of patients with low back pain who are referred to a spine surgeon actually require a surgical procedure. And because low back pain is such a common presenting complaint, many such patients often wait a long time for a surgery consult. In the December 19, 2018 issue of JBJS, Coyle et al. demonstrate that a simple, 3-item patient-administered questionnaire can identify those better suited for nonoperative management—and thus increase the likelihood that surgical candidates are seen by spine surgeons in an acceptable time frame.
All 227 of the Canadian patients enrolled in this randomized controlled trial received the questionnaire, which elicited information to distinguish between patients with leg-dominant radicular pain and those with back-dominant pain. Evidence-based guidelines recommend nonoperative management for most back-dominant pain, while patients with leg-dominant pain are more likely to need surgery. Researchers randomized 116 patients into an intervention group; these patients were triaged by a spine surgeon and then had their triage status upgraded if responses to the questionnaire indicated leg-dominant symptoms. The 111 patients in the control group were triaged only by a spine surgeon.
After triage, 33 of the 227 patients (15%) were recommended for a surgical procedure—16 from the intervention group and 17 from the control group. Of the 16 surgical candidates identified from the intervention group, 9 (56%) were re-prioritized on the basis of questionnaire results.
The median wait time for a consultation among the 16 surgical candidates in the intervention group was 2.5 months, compared with 4.5 months for the 17 surgical candidates in the control group. A significantly greater percentage of patients in the intervention group than in the control group were seen for a consult with a spine surgeon within the “acceptable” time frame of 3 months. Another benefit of the questionnaire approach evaluated in this study is that it helps identify nonsurgical candidates early, so they can be directed toward more appropriate treatment (such as physical therapy) rather than delaying treatment while waiting for a consult with a spine surgeon.
Although this study was conducted in the setting of the “nationalized” Canadian health care system, wait times to see orthopaedic surgeons and neurosurgeons are also long for many patients in many regions of the US. This questionnaire enhancement to triage could therefore be viable throughout North America, and perhaps beyond.
Confirmed: TXA Works Well in Adolescent Scoliosis Surgery
The evidence favoring tranexamic acid (TXA) for reducing surgical blood loss is ample and growing, but until now robust data were sparse regarding its efficacy in the setting of adolescent idiopathic scoliosis surgery. In the December 5, 2018 issue of The Journal of Bone & Joint Surgery, Goobie et al. report on a randomized, blinded, placebo-controlled trial showing that, in that population, TXA reduced perioperative blood loss by 27%, compared with blood loss in a placebo group.
Even with recent advances in scoliosis surgical technique, blood transfusions are common. And, because transfusions are associated with significant morbidity and mortality, limiting operative blood loss and reducing the need for transfusion have become focal points for orthopaedic surgeons.
In this Level-I trial, >100 patients between the ages of 10 and 18 years undergoing elective posterior instrumented spinal fusion were randomized to receive either TXA (infusion of a 50-mg/kg loading dose and a 10-mg/kg/h maintenance dose) or normal saline (delivered in the same way and dose) during surgery. The TXA group demonstrated an overall 27% reduction in cumulative blood loss and a 2-fold reduction in the percentage of patients with clinically relevant blood loss (defined as >20 mL/kg).
The cumulative effect of reduced blood loss was enhanced over time, with the positive effect of TXA being most evident in procedures lasting >4 hours. None of the patients in the TXA group required a transfusion or developed side effects such as thromboembolism or seizures.
In an interesting sidenote, the authors asked the participating orthopaedic surgeons, who were blinded to the randomization, to guess which group each patient had been assigned to by evaluating the relative ooziness of the surgical field. The surgeons guessed correctly 72% of the time.
Overall, these findings prompted the authors to conclude that “the use of TXA as part of a multimodal blood management strategy, as was employed in this study, should be considered the standard of care for patients undergoing surgery for adolescent idiopathic scoliosis.”
JBJS 100: Blount Disease, Low Back Pain
Under one name or another, The Journal of Bone & Joint Surgery has published quality orthopaedic content spanning three centuries. In 1919, our publication was called the Journal of Orthopaedic Surgery, and the first volume of that journal was Volume 1 of what we know today as JBJS.
Thus, the 24 issues we turn out in 2018 will constitute our 100th volume. To help celebrate this milestone, throughout the year we will be spotlighting 100 of the most influential JBJS articles on OrthoBuzz, making the original full-text content openly accessible for a limited time.
Unlike the scientific rigor of Journal content, the selection of this list was not entirely scientific. About half we picked from “JBJS Classics,” which were chosen previously by current and past JBJS Editors-in-Chief and Deputy Editors. We also selected JBJS articles that have been cited more than 1,000 times in other publications, according to Google Scholar search results. Finally, we considered “activity” on the Web of Science and The Journal’s websites.
We hope you enjoy and benefit from reading these groundbreaking articles from JBJS, as we mark our 100th volume. Here are two more:
Tibia Vara: Osteochondrosis Deformans Tibia
WP Blount: JBJS, 1937 January; 19 (1): 1
In this classic article, Blount detailed clinical and radiologic features of the affected lower extremities of 13 children with bowlegs. Nearly 80 years have passed since Blount’s original description, and not much more is known about this enigmatic developmental disorder. Given the potential for less postoperative morbidity, there has been a resurgence of “guided growth” strategies to treat this and other pediatric limb deformities.
Lumbar Disc Disorders and Low-back Pain: Socioeconomic Factors and Consequences
JN Katz: JBJS, 2006 April; 88 (Suppl 2): 21
The 21st century has brought with it a sharper focus on both the socioeconomic factors contributing to medical conditions and the socioeconomic consequences of those conditions. Back in 2006, Dr. Katz found that the total annual costs of low back pain in the US exceeded $100 billion, two-thirds of that in the form of indirect costs (e.g., lost wages and reduced productivity). He also found that fewer than 5% of patients who have a low back pain episode account for 75% of the total costs, prompting Dr. Katz to emphasize the ongoing “critical importance of identifying strategies to prevent these disorders and their consequences.”
More Evidence: Coordinated Care Reduces Risk of Second Fragility Fracture
Fracture liaison services and similar coordinated, multidisciplinary fragility-fracture reduction programs for patients with osteoporosis work (see related OrthoBuzz posts), but until now, the data corroborating that have come from either academic medical centers or large integrated health care systems. The November 7, 2018 issue of The Journal of Bone and Joint Surgery presents solid evidence from a retrospective cohort study that a private orthopaedic practice-based osteoporosis management service (OP MS) also successfully reduces the risk of subsequent fragility fractures in older patients who have already sustained one.
Sietsema et al. collected fee-for-service Medicare data for Michigan residents who had any fracture from April 1, 2010 to September 30, 2014 (mean age of 75 years). From that data, they compared outcomes for patients who received nurse-practitioner-led OP MS care from a single-specialty private orthopaedic practice within 90 days of the first fracture to outcomes among a propensity-score-matched cohort of similar patients who did not receive OP MS care. There were >1,300 patients in each cohort, and both groups were followed for an average of 2 years. The private practice’s OP MS services incorporated the multidisciplinary protocols promulgated by the American Orthopaedic Association’s “Own the Bone” program.
The cohort exposed to OP MS had a longer median time to subsequent fracture (998 versus 743 days), a lower incidence rate of any subsequent fracture (300 versus 381 fractures per 1,000 person-years), and higher incidence rates of osteoporosis medication prescriptions filled (159 versus 90 per 1,000 person-years). Over the first 12 months of the follow-up period, total medical costs did not differ significantly between the 2 cohorts.
These findings are consistent with those reported from academic or integrated health-system settings. According to the authors, this preponderance of evidence “emphasize[s] the importance of coordinated care in reducing subsequent fractures, lengthening the time to their occurrence, and improving patient outcomes.” Sietsema et al. conclude further that “the U.S. Medicare population would benefit from widespread implementation of such models in collaboration with orthopaedic providers and payers.”
JBJS 100: Epiphyseal Plate Injuries, Spinal Osteomyelitis
Under one name or another, The Journal of Bone & Joint Surgery has published quality orthopaedic content spanning three centuries. In 1919, our publication was called the Journal of Orthopaedic Surgery, and the first volume of that journal was Volume 1 of what we know today as JBJS.
Thus, the 24 issues we turn out in 2018 will constitute our 100th volume. To help celebrate this milestone, throughout the year we will be spotlighting 100 of the most influential JBJS articles on OrthoBuzz, making the original full-text content openly accessible for a limited time.
Unlike the scientific rigor of Journal content, the selection of this list was not entirely scientific. About half we picked from “JBJS Classics,” which were chosen previously by current and past JBJS Editors-in-Chief and Deputy Editors. We also selected JBJS articles that have been cited more than 1,000 times in other publications, according to Google Scholar search results. Finally, we considered “activity” on the Web of Science and The Journal’s websites.
We hope you enjoy and benefit from reading these groundbreaking articles from JBJS, as we mark our 100th volume. Here are two more:
Injuries Involving the Epiphyseal Plate
RB Salter, WR Harris: JBJS, 1963 April; 45 (3): 587
In addition to presenting the fracture classification, the authors laid the groundwork with basic principles of mechanical failure and vascularity of the physis. The authors then explain how physeal damage may arise from misalignment, crushing, or vascular interruption. This enduring orthopaedic schema lives on because of its clarity of presentation and its implications for treatment.
Pyogenic Osteomyelitis of the Spine
J Kulowski: JBJS, 1936 April; 18 (2): 343
In this 22-page analysis and discussion of 102 cases, the author notes that pyogenic osteomyelitis of the spine can affect any part of the vertebral system. In 1936—8 years after the discovery of penicillin—Kulowski said, “It may be axiomatically stated that operative intervention is imperative, as soon as the diagnosis is made with a reasonable degree of accuracy, when suppuration is present…,” adding that “the primary spinal focus requires the first attention of the surgeon.”
JBJS 100: Approach to the Lumbar Spine, Knee Flexion Contracture
Under one name or another, The Journal of Bone & Joint Surgery has published quality orthopaedic content spanning three centuries. In 1919, our publication was called the Journal of Orthopaedic Surgery, and the first volume of that journal was Volume 1 of what we know today as JBJS.
Thus, the 24 issues we turn out in 2018 will constitute our 100th volume. To help celebrate this milestone, throughout the year we will be spotlighting 100 of the most influential JBJS articles on OrthoBuzz, making the original full-text content openly accessible for a limited time.
Unlike the scientific rigor of Journal content, the selection of this list was not entirely scientific. About half we picked from “JBJS Classics,” which were chosen previously by current and past JBJS Editors-in-Chief and Deputy Editors. We also selected JBJS articles that have been cited more than 1,000 times in other publications, according to Google Scholar search results. Finally, we considered “activity” on the Web of Science and The Journal’s websites.
We hope you enjoy and benefit from reading these groundbreaking articles from JBJS, as we mark our 100th volume. Here are two more:
The Paraspinal Sacrospinalis-Splitting Approach to the Lumbar Spine
LL Wiltse, JG Bateman, RH Hutchinson, WE Nelson: JBJS, 1968 July; 50 (5): 919
In this classic 1968 JBJS paper, Wiltse and co-authors described a novel and innovative access route to the lumbar spine. Advantages included reduced blood loss, less muscle ischemia, and the preservation of spinous processes and intra-/supraspinous ligaments. The Wiltse approach still represents one of the main access routes to the lumbar spine.
Treatment of Knee Flexion Contracture Due to Central Nervous System Disorders in Adults
JN Martin, R Vialle, P Denormandie, G Sorriaux, H Gad, I Harding, O Dizien, T Judet: JBJS, 2006 April; 88 (4): 840
To address what was at the time a lack of interest among orthopaedic surgeons in treating spasticity in adults, these authors expanded upon earlier work studying the treatment of knee flexion contractures in this population. Their procedure included distal hamstring lengthening, a posterior capsulotomy in some of the knees, and use of a unilateral external fixator in most of the knees. Mean flexion contracture improved from a mean of 69° preoperatively to a mean of 6.2° at 1 to 5 years after surgery.
August 2018 Article Exchange with JOSPT
In 2015, JBJS launched an “article exchange” collaboration with the Journal of Orthopaedic & Sports Physical Therapy (JOSPT) to support multidisciplinary integration, continuity of care, and excellent patient outcomes in orthopaedics and sports medicine.
During the month of August 2018, JBJS and OrthoBuzz readers will have open access to the JOSPT article titled “Impact of Risk Adjustment on Provider Ranking for Patients With Low Back Pain Receiving Physical Therapy.”
The authors’ findings confirmed their hypothesis that robust risk adjustment is essential for objective comparison of patient-reported outcomes and for accurately reflecting quality of care among patients treated for low back pain.
What’s New in Spine Surgery 2018, Part II
Previously, Chad A. Krueger, MD, JBJS Deputy Editor for Social Media, selected what he deemed to be the most clinically compelling findings from among the more than 25 studies cited in the June 20, 2018 Specialty Update on Spine Surgery. In this OrthoBuzz post, Theodore J. Choma, MD, author of the Specialty Update on Spine Surgery, selected his “top five.”
Spondylolisthesis
–A registry study of 765 patients with adult isthmic spondylolisthesis and at least 2 years of post-treatment outcome data found that at 1 year, global-assessment improvements were reported in 54% of patients who underwent uninstrumented posterolateral fusion, 68% of patients who underwent instrumented posterolateral fusion, and 70% of patients who underwent interbody fusion. Although similar patterns were seen in VAS back pain scores and in 2-year data, fusion with instrumentation was associated with a higher risk of reoperation.
Acute Low Back Pain
–In a cost analysis using data from a previously published Level-II study that randomized 220 patients with acute low back pain to early physical therapy or usual (delayed-referral) care, authors concluded that the incremental cost of early PT was $32,058 per quality-adjusted life year and that early PT is therefore cost-effective.1
Metabolic Bone Disease
–A randomized trial of 66 women ≥50 years of age who had osteoporosis and had undergone lumbar interbody arthrodesis found that those who received once-weekly teriparatide for 6 months following surgery demonstrated higher fusion rates than those in the control cohort (69% versus 35%). Once weekly teriparatide may be worth considering to improve fusion rates in this challenging patient population.
Adult Deformity Correction
–To test the hypothesis that performing 3-column osteotomies more caudally in the lumbar spine might improve sagittal malalignment correction, authors analyzed 468 patients from a spine deformity database who underwent 3-column osteotomies.2 The mean resection angle was 25.1° and did not vary by osteotomy level. No variations were found in the amount of sagittal vertical axis or pelvic tilt correction, but lower-level osteotomies were associated with more frequent pseudarthroses and postoperative motor deficits.
Spinal Cord Injury
–Authors directly measured the mean arterial pressure and cerebrospinal fluid pressure in 92 consecutive patients with traumatic spinal cord injury. Using that data to indirectly monitor the patients’ spinal cord perfusion pressure,3 the authors found that patients who experienced more episodes of spinal cord perfusion pressures <50 mm Hg were less likely to manifest objective improvements in spinal cord function.
References
- Fritz JM, Kim M, Magel JS, Asche CV. Cost-effectiveness of primary care management with or without early physical therapy for acute low back pain: economic evaluation of a randomized clinical trial. Spine (Phila Pa 1976).2017 Mar;42(5):285-90.
- Ferrero E, Liabaud B, Henry JK, Ames CP, Kebaish K, Mundis GM, Hostin R, Gupta MC, Boachie-Adjei O,Smith JS, Hart RA, Obeid I, Diebo BG, Schwab FJ, Lafage V. Sagittal alignment and complications following lumbar 3-column osteotomy: does the level of resection matter?J Neurosurg Spine. 2017 Nov;27(5):560-9. Epub 2017 Sep 8.
- Squair JW, Bélanger LM, Tsang A, Ritchie L, Mac-Thiong JM, Parent S, Christie S, Bailey C, Dhall S, Street J,Ailon T, Paquette S, Dea N, Fisher CG, Dvorak MF, West CR, Kwon BK. Spinal cord perfusion pressure predicts neurologic recovery in acute spinal cord injury. 2017 Oct 17;89(16):1660-7. Epub 2017 Sep 15.
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