Today’s Top Story
Study: Pediatric scoliosis patients at Risser stage 0 may be at increased risk for surgery.
A study published in the Aug. 3 issue of The Journal of Bone & Joint Surgery examines the influence of the Risser sign on the need for surgery in children wearing orthoses for the treatment of adolescent idiopathic scoliosis (AIS). The research team conducted a prospective study of 168 pediatric patients with a curve magnitude between 25° and 45°; a Risser stage of 0, 1, or 2; and who had been prescribed bracing. All patients were followed until the cessation of bracing or the need for surgery. The research team found that prevalence of surgery or progression to a curve magnitude of ≥50°, was 44.2 percent for patients at Risser stage 0 (n = 120), 6.9 percent for patients at Risser stage 1 (n = 29), and 0 percent for patients at Risser stage 2 (n = 19). They note that patients at Risser stage 0 are at risk for surgery, even if they wear a brace for 12.9 hours per day—the number of hours linked with a successful outcome in the Bracing in Adolescent Idiopathic Scoliosis Trial. In addition, patients with open triradiate cartilage were at highest risk, especially those with curves of ≥30°. The research team writes that “Risser stage-0 patients should be prescribed a minimum of 18 hours of brace wear,” and that “bracing should be initiated for curves of <30° in patients at Risser stage 0, especially those with open triradiate cartilage.” Read the abstract…
Study: Zika virus may increase baby’s risk of arthrogryposis.
Findings published online in the journal The BMJ suggest that Zika virus infection in a pregnant woman may increase the risk of arthrogryposis in the baby. The researchers conducted a retrospective case series study of seven children with arthrogryposis and a diagnosis of congenital infection presumably caused by Zika virus during the Brazilian microcephaly epidemic. They found that the brain images of all seven children were characteristic of congenital infection and arthrogryposis, and that two children tested positive for IgM to Zika virus in the cerebrospinal fluid. Five of the children underwent brain computed tomography (CT) and magnetic resonance imaging (MRI) and the remaining two CT only. The researchers found that all the infants had malformations of cortical development, calcifications predominantly in the cortex and subcortical white matter, reduction in brain volume, ventriculomegaly, and hypoplasia of the brainstem and cerebellum. In addition, in four children, MRI of the spine displayed apparent thinning of the cord and reduced ventral roots. Read more…
Read the abstract…
FDA issues draft guidance recommendations to assist manufacturers that modify medical devices already on the market.
The U.S. Food and Drug Administration (FDA) has issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market. The recommendations apply to devices cleared through the FDA 510(k) premarket notification process. When finalized, they will replace an earlier guidance issued in 1997. Updates include:
- Guiding principles, including recommendations for manufacturers to conduct a risk-based assessment to determine whether a modification could significantly affect the safety or effectiveness of the device
- Updated sections and flow charts to provide more clarity to manufacturers on when they likely would be required to submit a new 510(k) for labeling, materials, technology, engineering, and performance changes
- Examples of specific device changes that would likely require a new 510(k) and ones that likely would not to help guide manufacturers during their own decision-making on whether to submit a new premarket notification
The agency also issued a separate draft guidance to cover software devices. The software draft guidance complements the general 510(k) modifications draft guidance. Read more…
Read the hardware draft guidance (PDF)…
Read the software draft guidance (PDF)…
WSJ article notes increased Medicare costs linked to in-office tests.
An article in The Wall Street Journal (WSJ) argues that an increased technology capacity for testing in physician offices may be associated with increased Medicare costs. The publication analyzed Medicare billing data and found that four of the top 10 fastest-growing Medicare services from 2012 to 2014 involved new devices. “Medicare’s tab for those four services rose by $123.5 million from 2012 to 2014, to $135 million,” the writers state. “In each case, a small cadre of doctors adopted the services much faster than their peers. Less than 10 percent of doctors accounted for more than half the rise in spending for each service, the Journal found. Journal studied only services performed throughout that period with at least $5 million in 2014 payments.”
None of the four services reviewed by WSJ are orthopaedic. Read more…
Last call to submit nominations for future AAOS leadership!
The 2017 Nominating Committee is actively soliciting your suggestions for individuals to serve in the following positions:
- Second Vice President
- Member-at-Large [No Age Designation]
- Member-at-Large [Under Age 45] (younger than age 45 on March 16, 2017)
- National Membership Committee Member
Descriptions of the responsibilities, desired experience, and time commitments associated with the positions are available online. Learn more about the positions and access the nomination form…(member login required)
Call for volunteers: CMS Technical Expert Panel on Transfer of Information at Post-Acute Care Admission/Discharge.
AAOS seeks to nominate members to the U.S. Centers for Medicare & Medicaid Services (CMS) Transfer of Information at Post-Acute Care Admission/Discharge Technical Expert Panel (TEP). The purpose of this project is to develop, maintain, re-evaluate, and implement measures that will drive high quality care in post-acute care through CMS quality reporting programs. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic. In addition, all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae, a biosketch, and a signed nomination form (obtained from the email below) to Kyle Shah by Aug. 16, 2016, at 11:59 p.m. (CT), at: email@example.com.
Learn more and submit your application…(member login required)
Last call: Committee positions closing soon!
A number of openings on the AAOS Committee Appointment Program website are closing soon. Act now to apply for the following positions:
- Annual Meeting Committee (one resident-at-large, one member-at-large opening; closes Aug. 15)
- Candidate, Resident, and Fellow Committee (chair, one candidate member, one resident member; Aug. 10)
- Central Evaluation Committee (Aug. 15)
- Hand (one member)
- Oncology (one member)
- Sports medicine (one member)
- CMS Technical Expert Panel (TEP) on Transfer of Information at Post-Acute Care Admission/Discharge (two members; Aug. 16)
- OKU Evaluation Committee (one member—oncology; Aug. 15)
- Sports Medicine Evaluation Committee (seven members; Aug. 10)
- Women’s Health Issues Advisory Board (Communications Cabinet liaison; Aug. 15)
Learn more and submit your application…(member login required)