N/A
N=100
Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
Plasma Cell Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT03078452 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist — 14; 9.5 Millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Power drill (Device); Jamshidi needle (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist |
14; 9.5 | — |
| SECONDARY Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire |
.66; .84; 1.62; 1.62; .89; .63 | — |
| SECONDARY Time Taken by the Procedure Measured in Seconds Using a Stopwatch |
7; 10.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03078452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.