title: A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy.
abstract: BACKGROUND
  Bone marrow aspiration and biopsy is an invasive procedure associated with morbidity and mortality risk. We compared a powered bone marrow aspiration and biopsy device to the traditional method by relatively assessing pain scores, procedure times, biopsy capture rates, quality of material retrieved, and safety and operator satisfaction.
  
  
  METHODS
  Two large academic medical centres participated in this trial. Patients were randomised to have procedures carried out using the powered system or the manual technique. A visual analogue scale pain score was recorded immediately following skin puncture and once again at the end of the procedure for each patient. Procedure time was measured from skin puncture to core specimen acquisition. Pathologic assessment of 30 randomised samples was carried out. Operator satisfaction with devices was measured on a scale of 0-10, with 10 as the highest rating.
  
  
  RESULTS
  Five operators from two sites enrolled 50 patients (powered, n=25; manual, n=25). Groups were evenly matched, with no significant differences in the means for age, weight and height. The powered system was superior to the manual system with respect to patient perceived pain from needle insertion (2.6±2.0 vs 4.1±2.5, p=0.022) and procedural time (100.0±72.8 s vs 224.1±79.0 s, p<0.001). Overall pain scores at the end of both procedures were comparable (3.2±2.2 vs 3.8±3.0, p=0.438). No complications were observed in either arm of the study. Blinded pathologic analysis of the specimens retrieved revealed that cores obtained using the powered system were longer and wider than those obtained using the manual technique (25.4±12.3 mm² vs 11.9±5.6 mm², p=0.001). For marrow aspiration, no difference was seen between groups for clot/particle spicules or smear spicules. Operator assessment favoured the use of the powered device.
  
  
  CONCLUSIONS
  Results of this trial suggest that the use of a powered bone marrow biopsy device significantly reduces needle insertion pain and procedural time when compared to a manual technique. The superior size and overall quality of core specimens retrieved by the powered device provides more material for pathologic evaluation, thereby increasing diagnostic yield and reducing the need for repeat procedures.
authors: Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, Texas, USA.
authors: Ronan T
authors: RT
authors: Swords
authors: Javier
authors: J
authors: Anguita
authors: Russell A
authors: RA
authors: Higgins
authors: Andrea C
authors: AC
authors: Yunes
authors: Michael
authors: M
authors: Naski
authors: Swaminathan
authors: S
authors: Padmanabhan
authors: Kevin R
authors: KR
authors: Kelly
authors: Devalingam
authors: D
authors: Mahalingam
authors: Thomas
authors: T
authors: Philbeck
authors: Larry
authors: L
authors: Miller
authors: Tatiana A
authors: TA
authors: Puga
authors: Francis J
authors: FJ
authors: Giles
authors: Marsha C
authors: MC
authors: Kinney
authors: Andrew J
authors: AJ
authors: Brenner