Article Text

PDF
A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy
  1. Ronan T Swords1,
  2. Javier Anguita2,
  3. Russell A Higgins1,
  4. Andrea C Yunes1,
  5. Michael Naski1,
  6. Swaminathan Padmanabhan1,
  7. Kevin R Kelly1,
  8. Devalingam Mahalingam1,
  9. Thomas Philbeck3,
  10. Larry Miller3,
  11. Tatiana A Puga3,
  12. Francis J Giles1,
  13. Marsha C Kinney1,
  14. Andrew J Brenner1
  1. 1Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, Texas, USA
  2. 2Universitary Hospital Gregorio Marañón, Madrid, Spain
  3. 3Vidacare Corporation, Shavano Park, Texas, USA
  1. Correspondence to Dr Andrew J Brenner, Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center, SA 7979 Wurzbach Rd., San Antonio, TX 78229, USA; brennera{at}uthscsa.edu

Abstract

Introduction 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.

  • Bone marrow
  • needle biopsy
  • surgical pathology
  • instrumentation
  • haematologic neoplasms/diagnosis

Statistics from Altmetric.com

Footnotes

  • Competing interests TP, LM and TAP are employees of Vidacare Corporation. This study was supported by funds from Vidacare Corporation.

  • Ethics approval Ethics approval was provided by University of Texas Health Science Center at San Antonio institutional review board (UTHSCSA IRB).

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.