Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Plasma Cell Myeloma

Intervention / Treatment
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* Device: Power drill
* Device: Jamshidi needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with existing plasma cell disorders and no history of psychiatric disorders who can receive conscious sedation are eligible to participate in the trial Exclusion Criteria: Pregnant women are excluded from participating in this study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (biopsy using power drill)<br>Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. | Device: Power drill<br>* Undergo bone marrow biopsy using power drill<br>|
| Active Comparator: Arm II (biopsy using Jamshidi needle)<br>Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7. | Device: Jamshidi needle<br>* Undergo bone marrow biopsy using Jamshidi needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the time of biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At the time of biopsy |