Published 12/1/2011

Second Look—Clinical News and Views

If you missed these Headline News Now items the first time around, AAOS Now gives you a second chance to review them. Headline News Now—the AAOS thrice-weekly, online update of news of interest to orthopaedic surgeons—brings you the latest on clinical, socioeconomic, and political issues, as well as important announcements from AAOS.

Class I Recall of Mizuho OSI Modular Table Systems
The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of Mizuho OSI Modular Table Systems due to reports of patient injury-related incidents. Incorrect removal of the T-pins that support the bottom base—instead of the T-pins that support the top—may result in a patient falling to the floor. Unexpected movement or tilting of the table may result in unanticipated movement and patient falls during surgery. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Questions should be directed to Mizuho at (800) 777-4674; adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program.

The AAOS has issued a Patient Safety Member Alert on this issue.

Return to sport after ACLR
An Australian study in the American Journal of Sports Medicine (AJSM) (October) suggests that less than 50 percent of patients who undergo anterior cruciate ligament reconstruction (ACLR) surgery return to preinjury levels of sports participation. The survey of 314 participants at a mean 39.6 months after ACLR surgery found that 45 percent were playing sport at their preinjury level and 29 percent were playing competitive sport. Overall, 93 percent of the study sample had attempted sport at some time after the ACLR surgery. Those who had not attempted their preinjury level of sport by 12 months after surgery were just as likely to have returned to preinjury level by 39 months after surgery as those who had played sport by 12 months.

Impact of market withdrawal of COX-2 inhibitor
Data presented at the 2011 annual meeting of the American College of Rheumatology indicate that the removal of rofecoxib from the market has been associated with an increase in falls and fractures among elderly patients with osteoarthritis (OA). Researchers reviewed the records of more than 10,000 patients aged 65 years and older who were diagnosed with OA between 2001 and 2009. They identified three analgesic prescriptions: narcotic analgesics (NAs) with or without other analgesics, COX-2 inhibitors with or without other analgesics, and NSAIDs. From 2001 to 2004, patients receiving only NA prescriptions increased from 8 percent to 20 percent of the population and doubled again to 40 percent by 2009. The incidence of falls or fractures increased from less than 1 percent of all patients in 2001 to 4 percent in 2009 and appeared to be associated with the increased use of NAs.

NSAIDs and cardiovascular risk
A study published online in the British Medical Journal finds that all included NSAIDs increased cardiovascular risk. The meta-analysis of 31 trials covered 116,429 patients who were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction, followed by lumiracoxib. Ibuprofen was associated with the highest risk of stroke, followed by diclofenac. Etoricoxib and diclofenac were associated with the highest risk of cardiovascular death.

PRP for tennis elbow
According to a study in AJSM (October), platelet-rich plasma (PRP) may be an effective treatment for chronic lateral elbow epicondylitis and superior to autologous blood in the short term. The randomized, controlled trial of 28 patients who received either 3 mL of autologous blood or 3 mL of PRP under ultrasound guidance found that patients in the PRP group had improved pain visual analog scale scores compared to patients in the autologous group at 6-week, 3-month, and 6-month follow up. However, the difference was only statistically significant at 6 weeks. No statistically significant difference in Liverpool elbow score was found between groups.