A Multicenter Randomized Clinical Trial Comparing a Powered Bone Marrow Biopsy System and Manual Bone Marrow Biopsy Procedures.

Bone marrow (BM) examination is instrumental in evaluating hematologic and oncologic disorders and monitoring the response to treatment in these patients. A powered BM sampling device was recently introduced and a multicenter randomized clinical trial was designed to determine if the new device has advantages over traditional manually-inserted needles in terms of decreased pain, decreased procedure time, higher biopsy core capture rate, ease of use, improved sample yield, and higher operator satisfaction scores.

The protocol was approved by the Western Institutional Review Board and the study was conducted in community-based cancer centers across the United States. Adult patients requiring BM aspirate and biopsy procedures were considered eligible for the study. After obtaining informed consent, patients were randomized to undergo a procedure using either a Manual device (e.g. Jamshidi) or a Powered device (OnControl 11 gauge/102mm Bone Marrow Biopsy System, Vidacare Corporation, Shavano Park, TX). Using the visual analog scale (VAS), pain scores were captured immediately following the procedure. Follow-up assessments for pain and complications were completed 1 and 7 days following the biopsy procedure. Procedure time was measured from needle-to-skin contact to core specimen ejection from the needle. Core specimens were submitted to a pathology reference laboratory for grading. Pathology assessment included measurement and overall quality of the specimen. Following an interim analysis, for subsequent patients enrolled in the study, an additional visual analog scale (VAS) pain score was recorded immediately following biopsy needle penetration of the iliac crest bone cortex. Statistics were calculated using t-test and chi-square, with an alpha-level of 0.05.

Thirteen operators from 10 sites participated in the study, and enrolled 102 patients (Powered, n=52; Manual, n=50). Of those patients, 56% were male. Their mean age was 66.3 ± 14.1 years with a mean height of 169.0 ± 10.2 cm and a mean weight of 76.3 ± 16.7kg. Forty-eight percent had lymphoproliferative disorders. There were no significant differences in the means for these variables between patients enrolled in the two arms of the study. This was the first BM biopsy for 69% and 56% of Powered and Manual patients, respectively. Measurement of needle insertion pain was done on a subset of patients and the VAS pain scores were not different between the arms (3.1 ± 3.1 for Powered [n=14] and 3.2 ± 2.9 for Manual [n=14]). Mean VAS scores for overall procedural pain were also not significantly different between the arms (4.8 ± 2.8 for Powered and 3.5 ± 2.3 for Manual [p=0.623]). However, one day after the procedure, more patients (67%) who underwent the Powered procedure were pain-free than those patients in the Manual group (33%; p=0.003). One week following the procedure, there was no difference in the proportion of patients who were pain-free (82.3% for Powered patients; 77.3% for Manual patients. Notably, mean procedure time was less than half among patients who underwent the Powered (96.0 seconds ± 80.9) compared with the Manual procedure [201.7 seconds ± 147.9; p<0.001]). Biopsy core acquisition success rate was similar between the arms (90.4% for Powered and 98% for Manual [p=0.205]). The mean length of biopsy core specimens was similar between the arms (Powered 13.3 ± 5.5 mm [n=9] compared to Manual 11.0 ± 5.5 mm [n=10]). There were two non-serious complications for the Powered (4%) and no complications for the Manual procedure (p=.0161).

The results of this first multicenter randomized control trial evaluating the OnControl Bone Marrow Biopsy System are promising. They suggest use of the Powered BM biopsy device markedly shortens the procedure time and reduces intermediate-term pain—important considerations for the quality of life for patients undergoing this procedure. Further studies with more BM biopsy and aspirate specimens are needed to confirm this beneficial effect.

Berenson:Vidacare Corporation: Research Funding. Yellin:Vidacare Corporation: Research Funding. Bojanower:Vidacare Corporation: Research Funding. Jonathan:Vidacare Corporation: Research Funding. Aboulafia:Vidacare Corporation: Honoraria. Upadhyaya:Vidacare Corporation: Research Funding. Blumenstein:Vidacare Corporation: Consultancy.