Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Not Applicable

Completed

• Conditions: Plasma Cell Myeloma
• Interventions: Device: Jamshidi needle; Device: Power drill

• Registration Number: NCT03078452
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2017-02-14
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

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Exclusion Criteria

• Pregnant women are excluded from participating in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (biopsy using Jamshidi needle)	Jamshidi needle	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.
Arm I (biopsy using power drill)	Power drill	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.

Primary Outcome Measures

Name	Time	Method
Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist	At the time of biopsy	Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.

Secondary Outcome Measures

Name	Time	Method
Time taken by the procedure measured in seconds using a stopwatch	At the time of biopsy	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.
Intensity of pain measured using visual analogue scale (VAS) pain questionnaire	At the time of, 30 minutes, 1, 3, and 7 days after biopsy	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.

Trial Locations

Locations (1)

Emory University/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States