Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders
Phase: NA
Conditions: Plasma Cell Myeloma
Sponsor: Emory University

Emory University 
March 25, 2015 
 
 
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Title: Comparison of quality of bone marrow biopsy and patient 
convenience and pain control by a battery powered drill versus 
conventional methods in patients with plasma cell disorders 
 
 
PRINCIPAL INVESTIGATOR: 
 
 
Name: 
Dr. Ajay Nooka 
Institution: 
Winship Cancer Institute 
Address: 
1365c Clifton Road 
 
City: Atlanta            State: Georgia             Zip: 30322 
Email: 
anooka@emory.edu     Phone:  404-778-3921    Fax:  404-778-
5530 
 
 
 
 
 
AIMS   
 
1. Primary endpoint - Assessing the quality and quantity of bone marrow 
core biopsies. 
2. Secondary endpoint –  
(a) Assessing the nature of pain by established VAS questionnaires. 
(b) Timing of the actual procedure 
 
BACKGROUND: 
 
Since the introduction of Jamshidi needle in 1971, we have not seen any 
advances in bone marrow sampling technology (Jamshidi & Swaim, 1971).   In 
2007, a new battery-powered bone marrow biopsy system was developed by 
OnControl Vidacare Corporation, Shavano Park, Texas, USA. This technology 
using a battery-powered drill to operate the needle to gain access to the posterior 
iliac bone was approved by the United States Food and Drug Administration 
(FDA) and currently commercially available.   
 
The traditional method for gaining bone marrow involves grinding a needle by 
hand through a patient’s skin and bone. 
 
The oncontrol bone marrow biopsy device consists of a powered driver and 
biopsy needle set. The lithium battery-powered driver resembles a small hand-
held drill and drives a needle into medullary cavity of the top ridge of your rear 
hip bone (iliac crest) to obtain the soft tissue located in the marrow space . The 

Emory University 
March 25, 2015 
 
 
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needle set consists of two parts: an outer cannula, 11 gauge × 4 inches (102 
mm) long; and a bevel-tip inner stylet, used to penetrate the cortex of the bone.  
 
This method is most commonly carried out on the top ridge of the rear hip bone 
with a patient in the right or left lateral position. Procedure performed under 
anesthesia (medication that causes numbness), local anesthesia is provided via 
infiltrating an adequate area of the periosteum. Commonly a skin insertion is 
made (with a lancet) and the needle is inserted through the skin, once the needle 
touches the bone the drill is started. During the procedure, you will hear a sound 
and feel the vibration of the needle. After the powered drill advances the needle 
into the marrow cavity the inner stylet is removed and the threaded cannula 
grabs the marrow. 
 
Marrow has both solid and liquid parts. Aspiration is the procedure used to collect 
the liquid part of the marrow. If the solid portion of the bone is sampled, this is 
called a biopsy. 
 
In the aspiration, an incision will be made and a needle inserted through the 
skin. Once the needle touches the bone, the power driver will be started and you 
may feel some vibration. Within a few seconds, your doctor will stop and take a 
sample of liquid marrow with a syringe. 
 
For the biopsy, after the aspirate has been collected, the power driver is 
restarted and, in a matter of seconds, your doctor will capture a sample of the 
solid marrow 
 
Few randomized controlled trials (RCTs) compared the use of the battery 
powered bone marrow biopsy system to the traditional manual methods however 
they have certain limitations.  Though the use of a powered drill is justified in 
selected patients, the results are not uniform. Swords et al reported that powered 
drill significantly reduces needle insertion pain and procedural time when 
compared to a manual technique (Swords et al., 2011)delivering similar quality of 
specimens by both method (Swords et al., 2010). In another RCT by Read et al 
evaluating hematologists-in-training, they were significantly faster and sampling 
was superior in quality when performed with the power drill (Reed et al., 2011). In 
the most recent RCT by Bucher et al, both methods produces similar results. In 
the absence of using conscious sedation, reported pain during the procedure is 
lower with the powered drill (Bucher et al., 2013). The limitations with these 
RCTs included relatively small number of patients, significant heterogeneity in 
patient population, and inclusion of patients with all indications. At our institution 
we have adapted to the power drill system and majority of the patients receive 
conscious sedation (by personal communication). We are proposing to conduct a 
RCT to identify the optimal procedure in patients with plasma cell disorders 
undergoing bone marrow biopsy due to technical challenges with concomitant 
osteoporosis/ osteopenia and ongoing bone loss in this particular set of patients. 
 

Emory University 
March 25, 2015 
 
 
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PATIENTS AND METHODS:  
 
Design  
 
Prospective randomized control trial in multiple myeloma patients.  
 
Outcomes: 
 
• 
Bone marrow core biopsy length (in mm)  and artifacts assessed by the 
pathologist blinded for the sample.  
• 
Intensity of Pain as measured via VAS (visual analogue scale) for pain, a 
10 point scale. 
• 
Time taken by the procedure measured in seconds. 
 
ELIGIBILITY CRITERIA 
 
All patients with existing plasma cell disorders and no history of psychiatric 
disorders and can receive conscious sedation are eligible to participate in the 
trial.   
 
EXCLUSION CRITERIA 
 
Pregnant women are excluded from participating in this study due to the 
uncertainty in the positioning of pregnant patients for the procedure.   
 
 
METHODOLOGY 
 
PATIENT IDENTIFICATION: 
The patients with plasma cell disorders undergoing bone marrow biopsy 
procedure at the procedure bay in Winship Cancer Institute will be identified 
weekly. The list of prospective patients will be shared among the clinical and 
research team.  
 
 
SEDATION/ANALGESIA: 
 
The eligible patients would be assessed whether they can receive consciuso 
sedation. Any contraindication to receive conscious sedation will exclude the 
patients from the study. Standard agents for conscious sedation as approved by 
the Emory University will be used. Standard personnel who can administer the 
conscious sedation will be able to perform the sedation and bone marrow biopsy.  
 
APPROACH: 
 

Emory University 
March 25, 2015 
 
 
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The eligible patients on the day of the procedure will be approached and the 
study strategy and the procedures are explained to the patients.  Informed 
consent is given to the patients and adequate time is given for the patient and 
family members to review and make a decision regarding participating in the 
study. Voluntary patients interested in participating in this non-therapeutic study 
after signing consents will be randomized to the power drill arm or the traditional 
(Jamshidi) bone marrow biopsy arm.   
 
RANDOMIZATION: 
 
All the study participants are randomized by using a shuffling card method. 100 
cards with predestinated procedure name (50 with traditional and 50 with 
powered biopsy) printed on them are shuffled and patient is asked to pick one 
card from the deck and he/she will be placed in the respective group. Every time 
the card is picked it is not replaced into the deck. This helps us to approximately 
achieve a balance in number of patients in each of the study groups.     
 
QUESTIONNAIRES: 
 
Patients are asked to fill out the VAS pain questionnaire before the start of the 
procedure and 30 minutes after the procedure, day 1, day 3, and day 7.  Subject 
will be given a VAS pain scale to score the intensity of the pain. Majority of the 
patients will return to Winship Cancer Institute in a few weeks to discuss the 
results of the bone marrow biopsy. Questionnaires will be collected during this 
visit. In the event that the patient is not returning to Winship, patients will use the 
return stamped envelope provided on the day of the procedure to return the 
questionnaires. Patients will be contacted over the phone as a reminder to return 
the completed the VAS questionnaire if not received during the follow-up clinic 
visit. For the secondary endpoint of time taken for the procedure, we will use a 
stopwatch from the beginning to the completion of the procedure (skin to skin) 
 
Variables to be considered during analysis: Sample size, length of procedure, 
pain intensity before procedure and at different time points after procedure, age, 
gender and BMI.    i 
 
Statistical methods: Analyzed using a SAS 9.1 version.  Continuous variables 
like, the bone marrow biopsy length, and time taken for procedure are studied 
with mean, median, range and standard deviation and compared by two-sample 
t-test. While the categorical variables, pain is studied with X2 or Mann Whitney U 
test or Fisher’s exact test. 
 
DATA SAFETY MONITORING PLAN 
The bone marrow drill procedure is done as a SOC at our institution, and we 
have established the safety of the procedure without any untoward events over 
the last 3-4 years. We have not proposed an interim analysis for futility or 
efficacy, taking into consideration that the final results of the study if fully 

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March 25, 2015 
 
 
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conducted will not harm a patient. Dr. Nooka will be the primary responsibility for 
overseeing the data and the interim analysis.   
 
 
DATA STORAGE AND PROTECTION 
All data will be maintained on the REDCap database supported by the Research 
and Woodruff Health Sciences IT (RWIT) Division at Emory University..  Access 
to the server is protected by (firewalls, encryption etc) and all accounts will be 
password protected. 
 
 
Confidentiality  
 
Your name, telephone number, social security number, residential and mailing 
addresses will be collected from your medical record for study related contact. 
Laboratory results, billing, clinical, radiology, physician, and hospital records will 
also be collected from your medical record.  
 
The samples and medical information we collect will have a code number and will 
not include your name, social security number, or other information that could 
identify you. 
For example: 
 
Mary Jones          becomes 
               31098756 
 
We will use this code to keep track of your samples and information. 
 
 
TIMELINE FOR COMPLETION:  04/01/2014-03/31/2015 
 
 
References 
 
Bucher, C. M., Lehmann, T., Tichelli, A., Tzankov, A., Dirnhofer, S., Passweg, J., 
& Rovo, A. (2013). Comparison of a powered bone marrow biopsy device 
with a manual system: results of a prospective randomised controlled trial. 
J Clin Pathol, 66(1), 24-28. doi: 10.1136/jclinpath-2012-201167 
Jamshidi, K., & Swaim, W. R. (1971). Bone marrow biopsy with unaltered 
architecture: a new biopsy device. J Lab Clin Med, 77(2), 335-342.  
Reed, L. J., Raghupathy, R., Strakhan, M., Philbeck, T. E., Kim, M. Y., Battini, R., 
. . . Pacello, T. (2011). The OnControl bone marrow biopsy technique is 
superior to the standard manual technique for hematologists-in-training: a 
prospective, randomized comparison. Hematol Rep, 3(3), e21. doi: 
10.4081/hr.2011.e21 

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March 25, 2015 
 
 
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Swords, R. T., Anguita, J., Higgins, R. A., Yunes, A. C., Naski, M., 
Padmanabhan, S., . . . Brenner, A. J. (2011). A prospective randomised 
study of a rotary powered device (OnControl) for bone marrow aspiration 
and biopsy. J Clin Pathol, 64(9), 809-813. doi: 10.1136/jclinpath-2011-
200047 
Swords, R. T., Kelly, K. R., Cohen, S. C., Miller, L. J., Philbeck, T. E., Hacker, S. 
O., . . . Brenner, A. J. (2010). Rotary powered device for bone marrow 
aspiration and biopsy yields excellent specimens quickly and efficiently. J 
Clin Pathol, 63(6), 562-565. doi: 10.1136/jcp.2009.072843 
 
 
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