Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Device: Power drill; Device: Jamshidi needle

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ajay Nooka, MD, MPH; Phone Number: 404-778-4191; Email: anooka@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University/Winship Cancer Institute
      • Contact: Jennifer Shipp; Phone Number: 404-778-4191; Email: jennifer.shipp@emory.edu
      • Contact: Eduardo Sanabria; Phone Number: 404-778-2164; Email: esanab2@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (biopsy using 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.	Device: Power drill; Undergo bone marrow biopsy using power drill
Active Comparator: Arm II (biopsy using 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.	Device: Jamshidi needle; Undergo bone marrow biopsy using Jamshidi needle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Ajay Nooka, MD, MPH, Emory University/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: IRB00075658; NCI-2017-00308 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); Winship2656-14 (Other Identifier: Emory University/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes