Second Look—Clinical News and Views

SURGIFLO Hemostatic Matrix products recalled
The U.S. Food and Drug Administration (FDA) has announced a Class I recall of Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin. The agency states that there is an issue within the packing process, where a cut could potentially breach the double Tyvek® pouch of the packaging. According to FDA, the product may cause serious adverse health consequences, including death. The affected products were manufactured from Sept. 16, 2011, through July 27, 2012, and distributed from Sept. 29, 2011, through Aug. 7, 2012.

Outcomes for obese patients with lumbar disk herniation
A study in the Journal of Bone & Joint Surgery–American (JBJS–A) (Jan. 2, 2013) finds that obese patients may realize less clinical benefit than nonobese patients from treatment of lumbar disk herniation. A data analysis of 336 obese patients and 854 nonobese patients enrolled in the Spine Patient Outcomes Research Trial for the treatment of lumbar disk herniation found that, with one exception (SF-36 pain scores), improvements over baseline in primary outcome measures at 4-year follow-up were significantly less for obese patients compared with nonobese patients in both surgical and nonsurgical treatment groups.

Study: ACP versus HA for gonarthrosis patients
According to data from an Italian study in the American Journal of Sports Medicine (December 2012), autologous conditioned plasma (ACP) may offer better clinical outcomes than hyaluronic acid (HA) for the treatment of gonarthrosis. The randomized, controlled trial involved 120 patients affected by clinically and radiographically documented gonarthrosis. Half received four intra-articular injections of ACP while the other half received four intra-articular injections of HA. Treatment with ACP injections was linked to significant improvement on the Western Ontario and McMaster (WOMAC) score shortly after final infiltration and a continuously improving sustained effect up to 24 weeks, at which point clinical outcomes were better than those achieved with the HA injections.

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