NCT03078452 · REGISTRY CONDITION SEARCH

Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-09-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist

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outcome · POSTED

Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire

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outcome · POSTED

Time Taken by the Procedure Measured in Seconds Using a Stopwatch

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Device: Power drill
label
Arm I (biopsy using power drill)
type
EXPERIMENTAL
description
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.
intervention Names
Device: Jamshidi needle
label
Arm II (biopsy using Jamshidi needle)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm I (biopsy using power drill)
description
Undergo bone marrow biopsy using power drill
name
Power drill
type
DEVICE
arm Group Labels
Arm II (biopsy using Jamshidi needle)
description
Undergo bone marrow biopsy using Jamshidi needle
name
Jamshidi needle
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 100
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
measure
Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
time Frame
At the time of biopsy

secondary Outcomes

description
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.
measure
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
time Frame
At the time of, 30 minutes, 1, 3, and 7 days after biopsy
description
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.
measure
Time Taken by the Procedure Measured in Seconds Using a Stopwatch
time Frame
At the time of biopsy

Full study description

brief 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice