Second Look- Clinical News and Views

MoM surveillance studies flawed
The postmarket surveillance studies that the Food and Drug Administration (FDA) ordered manufacturers of metal-on-metal (MoM) hip prostheses to undertake have several shortcomings that should be remedied, according to an opinion piece in the New England Journal of Medicine (NEJM) (June 20). Although it has been a year since the order, it is unclear whether any of the studies have even begun and manufacturers have no incentive to initiate studies that may yield adverse information on their products. Furthermore, each manufacturer is allowed to conduct its own study, possibly leading to difficult-to-compare results, and current law prevents FDA from requiring studies to last more than 3 years.

Viscosupplementation for knee OA
Information from a meta-analysis published online in Annals of Internal Medicine suggests that viscosupplementation for symptomatic knee osteoarthritis (OA) is associated with a clinically irrelevant benefit and an increased risk of serious adverse events. The review of data from 89 trials involving 12,667 adult patients found that 71 trials (9,617 patients) showed that viscosupplementation moderately reduced pain. However, 18 large trials with blinded outcome assessment (5,094 patients) demonstrated a clinically irrelevant effect size, while six trials (811 patients) showed that viscosupplementation increased—although not statistically significantly—the risk for flare-ups, and 14 trials (3,667 patients) showed that viscosupplementation increased the risk for serious adverse events.

Single-leg or double-leg spica cast
Treatment of pediatric femoral fractures with a single-leg spica cast is effective and safe, according to findings from a study in the Journal of Bone & Joint Surgery—American (June 13). In the prospective, randomized controlled study of 52 patients, aged 2 to 6 years, with a diaphyseal femoral fracture, 24 patients were treated with a single-leg cast and 28 were treated with a double-leg cast. All limbs healed in satisfactory alignment. Children treated with a single-leg cast were more likely to fit into car seats and fit more comfortably into chairs than those with double-leg casts, and their caregivers took less time off work than caregivers of patients with double-leg casts.

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