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.

Highlights

  • The human bone marrow is often evaluated in patients with various hematological disorders, including anemia, thrombocytopenia, pancytopenia, leukemia and other hematological malignancies.[1]

  • OnControl Bone Marrow (OBM) procedure under the supervision of an Statistical testing was conducted using SAS hematology fellows under the observation of 3 attending hematologist, before they were Version 9 for Windows

  • The fact that the primary endpoint of the study, the length of the marrow core, was objectively determined in the pathology laboratory, underscores the objectivity and old man hospitalized for gastrointestinal dle for bone marrow procedures (BMP) 40 years ago, few technical validity of the conclusion

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Summary

Introduction

The human bone marrow is often evaluated in patients with various hematological disorders, including anemia, thrombocytopenia, pancytopenia, leukemia and other hematological malignancies.[1] Multiple bone marrow procedures (BMP) are often required in patients with hematological malignancies to guide their treatment. Kim,[4] Ramakrishna Battini,[1,2] employed, the Jamshidi needle, is designed to Acknowledgement: the authors would like to yield both an aspirate and a marrow biopsy. Express appreciation for the others that con- Kim,[4] Ramakrishna Battini,[1,2] employed, the Jamshidi needle, is designed to Acknowledgement: the authors would like to yield both an aspirate and a marrow biopsy. express appreciation for the others that con-

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