April 13, 2011 (Chicago, Illinois) — The results from the first randomized placebo-controlled trial of a new rotary-powered bone marrow device are promising.
James Berenson, MD, from the Institute for Myeloma and Bone Cancer Research in West Hollywood, California, presented the results from a multicenter clinical trial, here at the Society of Interventional Radiology 36th Annual Scientific Meeting, involving 13 operators from 10 sites.
The trial was designed to compare the powered bone marrow device (11 gauge/102 mm OnControl Bone Marrow Biopsy System, Vidacare Corporation) with traditional manual devices (e.g., Jamshidi bone marrow biopsy needle) in terms of pain, procedure time, biopsy core capture rate, ease of use, sample yield, and operator satisfaction.
The trial involved 102 adult patients who required bone marrow sampling. The mean visual analog scale scores for overall procedural pain were similar between the powered and manual devices (4.8 ± 2.8 vs 3.5 ± 2.3; P = .623). The complication rate between the 2 devices was also similar (4% vs 0%; P = .495).
One day after the procedure, 67% of the patients in the powered group were pain free, compared with 33% of patients in the manual group (P =.003). The powered device was also able to acquire a larger volume of biopsy core specimen than the manual device (mean volume, 36.8 ± 21.2 vs 20.4 ± 9.0; P = .039).
Dr. Berenson spoke with Medscape Medical News about the study, explaining that "we use [the device] routinely for our bone marrows. . . . It is much quicker. It is easier to insert it in the bone marrow."
He acknowledged that, like all new surgical approaches, it requires a bit of practice for the person performing the procedure to become facile with it. He described the new device as a type of a drill that is especially useful for multiple sticks or any research that requires multiple pulls.
Dr. Berenson acknowledged that it is more expensive than manual devices, but concluded that "it does surpass the other available ways that we do bone marrow."
Dr. Berenson is an independent contractor of Vidacare Corporation.
Society of Interventional Radiology (SIR) 36th Annual Scientific Meeting: Abstract 26. Presented March 27, 2011.
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