Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available. Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system. 100 participants will be enrolled in this study at Emory University.
PRIMARY OBJECTIVE: I. Assessing the quality and quantity of bone marrow core biopsies. SECONDARY OBJECTIVES: I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires. II. Timing of the actual procedure. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo bone marrow biopsy using the power drill. ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle. All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Undergo bone marrow biopsy using power drill
Undergo bone marrow biopsy using Jamshidi needle
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Time frame: At the time of biopsy
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain.
Time frame: At the time of, 30 minutes, 1, 3, and 7 days after biopsy
Time Taken by the Procedure Measured in Seconds Using a Stopwatch
Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Time frame: At the time of biopsy
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