The OnControl Bone Marrow Biopsy Technique Is Superior to the Standard Manual Technique for Hematologists-In-Training: A Prospective, Rrandomized Comparison

Abstract

The purpose of this study was to compare a novel bone marrow device with the standard marrow needle in a prospective, randomized study in a teaching hospital employing hematologists-in-training. The new device, the OnControl Bone Marrow (OBM) Biopsy System, utilizes a battery-powered drill to insert the needle. Fifty-four bone marrows (27 standard and 27 OBM) were performed by 11 fellows under the observation and supervision of 3 attending hematologists and 1 research technologist. The primary endpoint of the study, the mean length of the marrow biopsy specimens, a surrogate for marrow quality, was determined by a pathologist in a blinded manner. The mean length of the marrow biopsy specimens was significantly longer (56%) for the OBM group (15.3 mm) than for the standard bone marrow (SBM) group (9.8 mm), P<0.003. An objectively determined secondary endpoint; mean procedure time, skin-to-skin; also favored the OBM group (175 s) versus the SBM group (292 s), P<0.007. Several subjective secondary endpoints also favored the OBM group. Only minor adverse events were encountered in the OBM and SBM study groups. It was concluded that bone marrow procedures (BMPs) performed by hematologists-in-training were significantly faster and superior in quality when performed with the OBM compared to the SBM. These data suggest that the OBM may be considered a new standard of care for adult hematology patients. OBM also appears to be a superior method for training hematology fellows.

Fluoroscopy-Guided Percutaneous Vertebral Body Biopsy Using a Novel Drill-Powered Device: Technical Case Series

“…As an alternative, a novel coaxial biopsy system powered by a handheld drill (OnControl; Vidacare Corporation, Shavano Park, TX, USA) has recently been introduced. Initial studies showed that iliac bone marrow aspiration and core biopsy could be performed safely and in less time with this drill-powered device compared with traditional manual devices, and that specimens obtained using the drill were histologically adequate [3][4][5][6]. Similar results were subsequently reported for CT-guided percutaneous bone biopsies of the axial and appendicular skeleton [7,8].…”

“…This was previously demonstrated with iliac wing bone marrow core biopsies [5], and this study shows similar results when obtaining vertebral body specimens. However, the higher yield obtained may be offset by the presence of crush artifact likely introduced by the power generated by drill assistance [3]. Crush artifact was present in three specimens (11 %; 3/28), which in one case (3.6 %; 1/28) precluded definitive diagnosis.…”

“…Prospective randomized studies found that compared with manual bone marrow biopsy devices, operators using the drill-assisted system obtained specimens of greater volume, more quickly, and with less pain [3][4][5][6]. In 2012, the Food and Drug Administration (FDA) granted 510(k) approval to expand the indications for the device to include bone biopsy based on unpublished data.…”

CT-guided radiofrequency ablation of osteoid osteoma using a novel battery-powered drill

“…We did not experience any device-related complications, which is in line with other reports using the OBM for other indications [10][11][12]. There are no device-related safety issues to be mentioned beside the fact that the OBM might not be recharged but has to be exchanged when the battery is empty.…”

“…The device allows to obtain large core specimen and handling has been shown to be easy to learn for hematologists in training, e.g., to perform bone biopsies of the iliac crest and subsequent bone marrow aspiration [10,11]. The drill has been proven to be safe to handle also under CT guidance to acquire evaluable bone specimens for histopathologic workup in oncologic patients [12].…”