Today’s Top Story
FDA announces sweeping plan to address opioid misuse.
The U.S. Food and Drug Administration (FDA) has announced plans to overhaul its policies regarding opioid medications. The agency notes that “drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally made fentanyl, are now the leading cause of injury death in the United States…” Aspects of the plan include:

  • Reexamination of the risk-benefit paradigm for opioids
  • Consultation with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved
  • Changes to immediate-release opioid labeling, including additional warnings and safety information
  • Updated risk evaluation and mitigation strategy requirements for opioids
  • Expanded access to, and increased development of, abuse-deterrent formulations of opioid products
  • Support of alternative pain management options

In addition, FDA plans to convene independent advisory committees made up of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties, and plans to strengthen the requirements for drug companies to generate post-market data on the long-term impact of using extended-release/long-acting opioids. Read more…
Read the FDA statement…

Other News

Studies assess effects of obesity on THA outcomes.
Two studies published in the Feb. 3 issue of The Journal of Bone & Joint Surgery (JBJS) investigate the effect of obesity on total hip arthroplasty (THA) procedures. In the first study, the authors reviewed prospective data on 21,361 consecutive hips (17,774 patients) treated with primary THA (mean body mass index [BMI] at the time of surgery 28.7 kg/m2, and found increasing BMI was associated with increased rates of reoperation, implant revision or removal, early hip dislocation, wound infection, and deep periprosthetic infection. However, they found no association between increasing BMI and any revision for mechanical failure or aseptic implant loosening, and noted an inverse correlation between increasing BMI and risk of revision for bearing wear. Read the abstract…
     In the second study, the researchers conducted a matched cohort study of 48 hips (45 patients) with a minimum BMI of 50 kg/m2 and 135 non-obese patients (BMI <30 kg/m>2). At mean 6-year follow-up, they found that patients in the high-BMI group were at increased risk of complications compared to controls. In addition, patients in the high-BMI group displayed significantly lower mean values for Harris hip score, SF-36 Physical Component Summary score, SF-36 Mental Component Summary scores, and UCLA activity score. Read the abstract…

Study: Pain associated with calcific tendinitis may be linked to formation of new blood vessels and nerves.
Data published in the Feb. 3 issue of JBJS suggest that pain associated with calcific tendinitis may be caused by the induction of an inflammatory response within the tendon associated with the formation of new blood vessels and nerves. The research team drew samples from the supraspinatus tendon adjacent to the calcific lesion from 10 patients with calcific tendinitis, the torn supraspinatus tendon of 10 patients undergoing rotator cuff repair, and the subscapularis tendon of 10 control patients undergoing a stabilization surgical procedure. Compared with patients in the rotator cuff and control groups, they found a two- to eightfold increase of nerve markers, neovascularization, macrophages, M2 macrophages, and mast cells in the calcific tendinitis group. Further, the research team noted that increased nerve counts positively correlated with more frequent extreme pain and increased neovascularization, and increased counts of CD68 macrophages, M2 macrophages, and mast cells. Read more…
Read the abstract…

Study: Surgical safety checklists may help reduce length of stay and 90-day mortality rates.
According to a study conducted in Italy and published online in the journal JAMA Surgery, implementation of surgical safety checklists (SSCs) may be associated with a reduction in 90-day mortality rates and postoperative length of stay. The authors conducted a retrospective analysis of 10,741 patients at a single center, 5,444 of whom underwent surgery prior to implementation of an SSC program, and 5,297 of whom underwent surgery after implementation. They found a non-significant reduction in 30-day all-cause mortality, but noted a 27 percent reduction in 90-day all-cause mortality. In addition, the authors noted an adjusted length of stay of 10.4 days in the preimplementation cohort and 9.6 days in the postimplementation cohort. The authors write that due to the study design, the data do not prove causality. Read more…
Read the abstract…

Study: Is joint mobilization and stretching better than steroid injection for plantar fasciitis?
Data published in the February issue of the journal Foot & Ankle International compares effectiveness of joint mobilization combined with stretching exercises against steroid injection for the treatment of plantar fasciitis. The researchers conducted a randomized, controlled study of 43 patients with plantar fasciitis who were treated with joint mobilization and stretching (n = 22; nine visits over 3 weeks) or a single steroid injection (n = 21). Compared to baseline, they noted significant improvement in pain relief and functional outcomes across both groups at 3-, 6-, and 12-week follow-ups. However, at the 12-week and 1-year follow-ups, pain and functional outcomes were significantly improved in only the mobilization and stretching group. Between-group differences favored the steroid group at 3-, 6-, and 12-week follow-ups for pain relief and functional outcomes, but no significant differences were detected in measured outcomes at 1-year follow-up. Read the abstract…

Senate bill calls for increased oversight of reusable medical devices.
The Seattle Times reports that a proposal under consideration in the U.S. Senate would, if enacted, require manufacturers of reusable medical devices to submit cleaning instructions and associated support data to FDA before the devices would be cleared for market. In addition, the bill would provide FDA with the authority to refuse or deny clearance based on whether such instructions are likely to be adequate in real-world situations. The proposal is based on a series of incidents in which at least 39 people were sickened and 18 died after infection linked to contaminated duodenoscopes. Read more…

Study: Brain needs time to recover after mTBI.
Findings from a study published online in The American Journal of Pathology suggest that repeat mild traumatic brain injury (rmTBI) may be associated with progressive white matter pathology that continues for months after the final impact. The research team used a mouse model to describe the effects of 30 repeat mTBI (rmTBIs), and found that single mTBI was associated with a brief loss of consciousness and a transient reduction in dendritic spines, reflecting a loss of excitatory synapses, but not axonal injury, neuroinflammation, or cell death in gray or white matter. However, 30 rmTBIs was linked with white matter pathology characterized by positive silver and Fluoro-Jade B staining, and microglial proliferation and activation—a pathology that continued to develop through 60 days and was still apparent at 365 days after injury. The research team states that evidence suggests that the brain can recover from mTBI if given enough time to rest and recover, but not when impacts occur too close together. Read more…
Read the abstract…

Call for volunteers: AMA representatives to Joint Commission Professional and Technical Advisory Committees.
AAOS seeks to nominate individuals to serve as American Medical Association (AMA) alternate representatives to the following Joint Commission Professional and Technical Advisory Committees (PTACs): Home Care Accreditation Program PTAC and Hospital Accreditation Program PTAC. PTAC Representatives and Alternate Representatives may not be board members, advisory committee members, elected officers, employees, or paid independent contractors of other accrediting organizations, and may not hold leadership positions in healthcare organizations accredited by other accrediting organizations. Applicants must be AAOS active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic, as well as active members of AMA at the time of appointment and throughout the duration of their term. In addition, all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae (no more than 3 pages), a 100-word biosketch, a letter of interest highlighting his or her expertise in the subject area and a statement that he or she is able to participate in full capacity, and an AMA nomination form. The nomination form can be obtained by emailing Kyle Shah at the address below. All supporting materials must be submitted by March 6, 2016 at 11:59 p.m. CT, to Kyle Shah at: shah@aaos.org
Learn more and submit your application…(member login required)