Lots of Ortho Device Recalls with 510(k) Process
Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that 510(k)-cleared devices were 11.5 times more likely to be recalled than devices cleared through the more stringent Premarket Approval (PMA) process.
The authors encourage orthopaedic surgeons who are thinking about using a new device in patients to consider how the device was approved. “If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety,” they caution.
The pie chart above shows that from November 2002 to December 2012, 41% of all recalled devices from the 20 companies with the highest number of recalls were of orthopaedic origin.
JBJS Reviews Editor’s Choice–Steroid Injections in Patients with Diabetes
It is well known that parenterally administered steroids affect the metabolism of glucose and cause abnormal blood glucose levels in diabetic patients. For this reason, physicians are careful regarding the use of parenteral steroids in the presence of diabetes. However, one of the most common procedures in the outpatient setting, a local, intra-articular steroid injection, seems to be done without as much consideration or knowledge regarding the potential systemic effects of peripherally absorbed steroid. In the March 2016 issue of JBJS Reviews, Choudhry et al. address the question of potential abnormal blood glucose levels in diabetic patients who undergo intra-articular steroid injection.
The investigators performed a literature search of 4 different databases and identified 532 manuscripts. After applying inclusion criteria, 7 studies with a total of 72 patients were analyzed. The studies showed that a rise in blood glucose levels follows intra-articular steroid injection. Four of the 7 studies showed that this rise was substantial. Indeed, peak values as high as 500 mg/dL were reached. In most patients, hyperglycemia occurred within 24 to 72 hours after injection; however, peak increases in blood glucose levels did not occur immediately in all patients and in some cases took several days to occur.
Diabetes mellitus affects 9.3% of the general population of the United States, and nearly half of adults with diabetes also have osteoarthritis. Based on the data presented in this report, careful consideration should be given to administering intra-articular steroids to patients with diabetes. Indeed, current evidence suggests that diabetic patients should be advised to monitor their blood glucose levels following an intra-articular steroid injection. Patients with Type-1 diabetes should check their blood glucose levels 3 to 4 times a day for 7 days and should seek advice from a physician if levels exceed 360 mg/dL. Patients with Type-2 diabetes should check blood glucose levels at least twice a day for 7 days and should seek advice from a physician if levels exceed 540 mg/dL.
Intra-articular steroid injection is one of the most frequently performed outpatient procedures, and the data in this report shed important light on this process. This is a “must read” article.
Thomas Einhorn, Editor
JBJS Reviews
Promising Phase 1 Results from ACL “Bridge” Repair
Last week, The Boston Globe reported that Martha Murray, MD, an orthopaedist at Boston Children’s Hospital, had announced results from the Phase 1 safety study of “bridge-enhanced” ACL repair, which OrthoBuzz first told you about in April 2015 (see “ACL Self-Repair Moving Toward Reality”). According to the Globe, “all 10 BEAR [Bridge-Enhanced ACL Repair] patients…have new, healthy ACLs regrowing where there were originally tears.”
The Globe article quoted Jo Hannafin, MD, past president of the American Orthopaedic Society for Sports Medicine (AOSSM), as saying that BEAR “has the potential to be a game-changer.” But Dr. Hannifin was quick to add that “these patients will have to be followed for a minimum of two years to determine whether the ACL heals and does that healed ACL stay competent or stretch over time and fail.”
Another key question is how much arthritis will develop in the BEAR knees 15 or 20 years from now. In preclinical studies of BEAR on pigs’ knees, the rates of subsequent knee arthritis were lower than those seen with traditional reconstruction techniques.
The Globe reported that Dr. Murray will start enrolling 100 patients for a Phase 2 randomized trial this summer. She will be seeking people from 14 to 35 years of age with torn ACLs that occur within 30 days of enrollment. Additional inclusion criteria include a tibial ligament stump that is at least 6 to 8 mm in length and no serious concomitant knee damage. Two-thirds of the Phase 2 study enrollees will be randomized to undergo the BEAR procedure, and the other group will undergo traditional ACL reconstruction. Patients will be followed for up to 10 years to assess the competence of the repair and track the development of arthritis.
Click here for more information about the BEAR trials.
OrthoBuzz will keep you posted on this important ongoing research.
BMP vs Autograft for Instrumented Posterolateral Lumbar Fusion
In diligent efforts to improve osseous bridges when performing spinal fusion surgery, orthopaedists have been using harvested allograft bone for more than a century and bone morphogenetic protein (BMP) for nearly a half century. Now, a European multicenter, randomized trial by Delawi et al., in the March 16, 2016 Journal of Bone & Joint Surgery, has compared overall success (defined as a combination of CT-determined fusion rates and clinical results at 12 months) between the two approaches among 113 patients.
This was a non-inferiority trial, and the BMP formulation used (Osigraft BMP-7, known commonly as OP-1 and available in the US in a similar formulation known as OP-1 Putty) was not non-inferior to iliac crest autograft. To clarify the potentially confusing double negative: OP-1 was less successful than autograft, due primarily to lower fusion rates. There were no significant between-group differences in clinical outcomes as measured by scores on the Oswestry Disability Index, although the authors added that “our follow-up period of one year may have been too short to show differences in clinical results.”
Delawi et al. conclude that, based on their findings, “use of OP-1 in place of autologous iliac crest bone graft in instrumented posterolateral lumbar fusions cannot be recommended.” That conclusion is echoed by commentator Jeffrey Coe, MD, who sees these findings as “another bit of evidence against the use of rhBMP-7 as a substitute for [iliac crest bone grafts] in posterolateral spinal fusion.”
OR Table Failure Spotlights Equipment Challenges
What happens when hospital-specified, -purchased, and -owned equipment fails? How is information about such failures distributed within the hospital and to the orthopaedic community at large? Which parties—doctors, OR staff, manufacturers, or hospital administrators—should assume responsibility for reporting these failures to the FDA to prevent patient harm?
The March 2016 “Case Connections,” springboarding from a case report about a failed trauma table in the March 9, 2016, edition of JBJS Case Connector, addresses those questions.
It’s All Happening at JBJS.org
The best of what the JBJS family of publications offers is at jbjs.org. That includes access to our online journals—JBJS Reviews, JBJS Case Connector, and JBJS Essential Surgical Techniques.
Whether you subscribe to the full suite of JBJS products or only the flagship Journal of Bone & Joint Surgery, activating your online subscription improves all-around access to the most authoritative orthopaedic information. It’s easy:
- Go to https://store.jbjs.org/activatecustomer.
- Enter your subscriber number (located on the mailing label of your printed JBJS issue).
- Create a password and complete the registration form. Be sure to indicate your subspecialty.
During the AAOS 2016 Annual Meeting, JBJS showcased new innovative features and resources, including Key Procedure Video Articles, demonstrating core orthopaedic procedures.
If you have any questions or need further assistance accessing content or activating your account, please contact us via email at customerservice@LWW.com or call us at 800-638-3030.
Are You Ready for a Mass-Casualty Disaster?
Disaster Response Management Protocol for Departments of Orthopaedic Surgery
The events in Brussels this week and in Paris last November should prompt everyone in the orthopaedic community to ask whether their department and their hospital are prepared for a disaster response. The use of high-energy explosives during such attacks results in mass casualties with many orthopedic injuries not commonly encountered outside of battlefields. It is critical for the orthopaedic community to be prepared.
JBJS Reviews, in collaboration with the Orthopaedic Trauma Association (OTA) and its Disaster Management and Preparedness Committee, is providing you with some basic information to help you plan for a terrorist attack (click link above).
What’s New in Pediatric Orthopaedics
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 cited in the February 17, 2016 Specialty Update on pediatric orthopaedics:
Guidelines and AUCs
–The AAOS updated its clinical practice guidelines on the treatment of pediatric diaphyseal femoral fractures1 and adopted appropriate use criteria (AUC) for pediatric supracondylar humeral fractures with vascular injury.2
Spine
–A matched case control study of surgical spinal procedures found that neuromuscular scoliosis, weight for age ≥95th percentile, ASA score of ≥3, and prolonged operative time were associated with a higher risk of surgical site infection.3
–Several groups, including the Scoliosis Research Society and POSNA, endorsed the definition of early-onset scoliosis as “scoliosis with onset less than the age of ten years, regardless of etiology.”4, 5
–A prospective randomized study found that preoperative education and orientation for scoliosis surgery paradoxically increased immediate postoperative anxiety among patients and caregivers, relative to controls who received standard perioperative information.6
–A randomized trial investigating perioperative blood loss and transfusion rates in patients undergoing posterior spinal arthrodesis for adolescent idiopathic scoliosis found that tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rates when compared with placebo.
Hip
–A study of 30 patients with severe stable slipped capital femoral epiphysis found that good or excellent results were achieved over 2.5 years in a higher proportion of those receiving a modified Dunn realignment compared with those treated with in situ fixation. The reoperation rate was greater in the in situ fixation cohort.7
–A prospective study analyzing complications after periacetabular osteotomy for acetabular dysplasia using the modified Clavien-Dindo grading scheme found grade III or IV complications in 5.9% of 205 patients, with a nonsignificant trend associating complications with male sex and obesity.
–A registry-based study found that, compared with matched controls, patients with Legg-Calve-Perthes disease had an elevated hazard ratio of 1.5 for ADHD, 1.3 for depression, and 1.2 for mortality. It remains unclear whether patients with Legg-Calve-Perthes disease would benefit from routine psychiatric screening.8
Sports Medicine
–A case control study of 822 injured athletes and 368 uninjured athletes found that overuse injuries represented 67.4% of all injuries. The risk of serious overuse injury was two times greater if the weekly hours of sports participation were greater than the athlete’s age in years.9
–A meta-analysis of initial nonoperative treatment compared with operative treatment of ACL tears in children and adolescents noted instability and pathologic laxity in 75% of patients with nonoperative treatment compared with 14% of patients following reconstruction.10
Trauma
–A review of more than 4,400 supracondylar humeral fractures with isolated anterior interossesous nerve palsies but without sensory nerve injury or dysvasculartity found that postponing treatment for up to 24 hours did not delay neurologic recovery.
–A randomized controlled trial investigating the effectiveness of analgesics during intraossesous pin removal found that acetaminophen and ibuprofen were clinically equivalent to placebo in terms of pain reduction and heart rate.
Foot and Ankle
–A study exploring risk factors for failure of allograft bone after calcaneal lengthening osteotomy found a lower risk of failure with tricortical iliac crest allograft relative to patellar allograft. The risk of radiographic graft failure increased with patient age.11
–A prospective nonrandomized study of symptomatic planovalgus feet comparing subtalar arthroereisis with lateral column lengthening found similar postoperative improvements and complication rates in both groups after one year.12
Musculoskeletal Infection & Neuromuscular Conditions
–A cohort study of 869 children with osteomyelitis, septic arthritis, pyomyositis, or abscess concluded that routinely culturing for anaerobic, fungal, and acid-fast bacterial organisms is not recommended except in patients with a history of penetrating injury, immunocompromise, or failure of primary treatment.
–A prospective study comparing tendon transfers, botulinum toxin injections, and ongoing therapy in children with upper-extremity cerebral palsy found that tendon transfer demonstrated greater improvements than the alternatives in joint positioning during functional tasks and grip and pinch strength.
References
- American Academy of Orthopaedic Surgeons.Guideline on the treatment of pediatric diaphyseal femur fractures. 2015.http://www.aaos.org/Research/guidelines/PDFFguideline.asp.
- American Academy of Orthopaedic Surgeons.Appropriate use criteria: pediatric supracondylar humerus fractures with vascular injury. 2015.http://www.aaos.org/research/Appropriate_Use/pshfaucvascular.asp.
- Croft LD, Pottinger JM, Chiang HY, Ziebold CS, Weinstein SL, Herwaldt LA. Risk factors for surgical site infections after pediatric spine operations. Spine (Phila Pa 1976). 2015 Jan 15;40(2):E112-9
- El-Hawary R, Akbarnia BA. Early onset scoliosis – time for consensus. Spine Deformity. 2015 Mar;3(2):105-6
- Skaggs DL, Guillaume T, El-Hawary R, Emans J, Mendelow M, Smith J. Early onset scoliosis consensus statement, SRS Growing Spine Committee, 2015. Spine Deformity. 2015;3(2):107.
- Rhodes L, Nash C, Moisan A, Scott DC, Barkoh K, Warner WC Jr, Sawyer JR, Kelly DM.Does preoperative orientation and education alleviate anxiety in posterior spinal fusion patients? A prospective, randomized study. J Pediatr Orthop. 2015 Apr-May;35(3):276-9.
- Novais EN, Hill MK, Carry PM, Heare TC, Sink EL. Modified Dunn procedure is superior to in situ pinning for short-term clinical and radiographic improvement in severe stable SCFE. Clin Orthop Relat Res. 2015 Jun;473(6):2108-17. Epub 2014 Dec 12
- Hailer YD, Nilsson O. Legg-Calvé-Perthes disease and the risk of ADHD, depression, and mortality. Acta Orthop. 2014 Sep;85(5):501-5. Epub 2014 Jul 18.
- Jayanthi NA, LaBella CR, Fischer D, Pasulka J, Dugas L. Sports-specialized intensive training and the risk of injury in young athletes: a clinical case-control study. Am J Sports Med. 2015 Apr;43(4):794-801. Epub 2015 Feb 2.
- Ramski DE, Kanj WW, Franklin CC, Baldwin KD, Ganley TJ. Anterior cruciate ligament tears in children and adolescents: a meta-analysis of nonoperative versus operative treatment. Am J Sports Med. 2014 Nov;42(11):2769-76. Epub 2013 Dec 4.
- Lee IH, Chung CY, Lee KM, Kwon SS, Moon SY, Jung KJ, Chung MK, Park MS. Incidence and risk factors of allograft bone failure after calcaneal lengthening. Clin Orthop Relat Res. 2015 May;473(5):1765-74. Epub 2014 Nov 14.
- Chong DY, Macwilliams BA, Hennessey TA, Teske N, Stevens PM. Prospective comparison of subtalar arthroereisis with lateral column lengthening for painful flatfeet. J Pediatr Orthop B. 2015 Jul;24(4):345-53.
UKA-to-TKA and TKA-to-TKA Revisions: Outcomes Same
Many surgeons recommend primary unilateral knee arthroplasty (UKA) over primary total knee arthroplasty (TKA) or tibial osteotomy for younger patients with unicompartmental knee osteoarthritis. Some do so believing that the results of any subsequent revision to TKA (UKA → TKA) will be better than a revision of a primary TKA to a second TKA (TKA → TKA).
A comparative, registry-based study by Leta et al. in the March 16, 2016 JBJS found that both revision categories yielded essentially the same outcomes. The authors found no significant differences between the two strategies in terms of overall implant survival rate or risk of re-revision, or in several patient-reported outcomes: the EuroQol EQ-5D, KOOS, and VAS pain and satisfaction scores. Two notable exceptions were as follows:
- The risk of re-revision was twice as high for TKA → TKA patients who were older than 70 years of age
- UKA → TKAs were more often re-revised because of a loose tibial component and pain alone, while TKA → TKAs were more often re-revised because of deep infection.
With few significant outcome differences, commentator Geoffrey Dervin, MD suggests that “patients facing the initial decision between UKA and TKA should focus more on differences in perioperative morbidity, clinical outcomes, and satisfaction” from the primary procedure rather than on the outcomes of revision should it be required.
JBJS Classics: Antibiotics and Open Fractures
OrthoBuzz regularly brings 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 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.
From the time of Hippocrates until after the American Civil War, open fractures and other wounds prone to sepsis were fatal injuries in approximately 50% of patients, and amputation of the affected limb was recognized as lifesaving treatment. With the adoption of antisepsis and formal surgical débridement in the late 19th century, improved stabilization techniques in the 20th century, and the introduction of antibiotics, death as an outcome was virtually eliminated, but nonunion with or without infection remained challenging complications.
In the 1960s, reports concluding that in open fracture care “prophylactic antibiotics were of questionable value” created great debate and controversy among surgeons. The pioneering 1974 JBJS study by Patzakis et al., titled “The Role of Antibiotics in the Management of Open Fractures,” addressed this controversy by asking and answering three key questions:
- Is antibiotic prophylaxis worthwhile in open fractures?
- Which organisms cause the infections?
- Which antibiotics are effective?
The study demonstrated that nearly two-thirds of wounds caused by direct injury and an even higher rate of gunshot wounds were contaminated. That finding, along with the fact that several days must elapse before a culture can be considered truly sterile, makes true “prophylaxis” in open fractures practicable only if antibiotics are applied to all patients. Patzakis et al. also stressed that antibiotic treatment is not a substitute for the critically important practice of extensive surgical debridement of all devitalized tissue. Urgent surgical irrigation and debridement remain the mainstay of infection eradication, although questions persist regarding the optimal irrigation solution, volume, and delivery pressure.
I agree with the authors of this classic article that the term “prophylaxis” is not appropriate because these wounds should presumptively be considered contaminated and treated with effective antibiotics. Wound sampling has a poor predictive value in determining subsequent infections, so a first-generation cephalosporin should be administered as soon as possible, with or without coverage for gram-negative bacteria. In addition, as Lawing et al. found in a 2015 JBJS study, local aqueous aminoglycoside administration as an adjunct to systemic antibiotics may be effective in lowering infection rates in open fractures.
This classic prospective study by Patzakis et al. in the 1970s has prompted us to ask and pursue answers to many more clinical questions regarding open-fracture infections. For example, the optimal duration of antibiotic administration has not been well defined, but they should be continued for more than 24 hours. The evidence to support either extending the duration or broadening the antibiotic protocol for Gustilo type III wounds remains inconclusive, and more investigation into this question with higher-level research methods is needed.
Konstantinos Malizos, MD, PhD
JBJS Deputy Editor
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