Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study

Summary

Bone marrow biopsies are routinely performed by the Medicine Bedside Procedure Team service at Froedtert Hospital. Typical indications for inpatient bone marrow biopsies include evaluations for cytopenia, leukemia, lymphoma, myelodysplastic syndrome, or plasma cell dyscrasia. The bone marrow is sampled from the posterior iliac crest, ideally by drilling into the posterior superior iliac spine (PSIS). The Arrow® OnControl® Powered Bone Access System is utilized for this process. Most frequently, the location of the PSIS is estimated by using palpation of landmarks, such as the lateral iliac crests, spinous processes, sacrum, and the PSIS itself. Additionally, when using lidocaine to anesthetize the site, the needle is maneuvered to locate the most superficial portion of the PSIS, confirming the optimal drill anchor site. The correct direction/angle of the drill is estimated based on the orientation of the patient, typically directing it perpendicular to the coronal plane.

Palpating landmarks to identify the posterior superior iliac spine is often difficult due to patient body habitus. Ultrasonography allows for accurate identification of the PSIS. It allows the clinician to pinpoint the best entry point in the skin and optimal drill angle to drive the needle perpendicular to the coronal plane. Furthermore, it allows the clinician to measure the distance from the skin to the PSIS, ensuring the drill bit is anchored onto the correct site.

The benefits of an ultrasound approach have not been well documented. Therefore, this study will seek to provide evidence of benefits, or lack thereof, in using ultrasound for bone marrow biopsies. This will be achieved using a two-arm, open-label, randomized study design which will compare patient outcomes, as measured by pain assessment, bone marrow biopsy procedure metrics, and bone marrow biopsy sample quality, between subjects that have undergone the procedure using either the control landmark palpation method or ultrasound-assisted technique to properly identify the PSIS.

Conditions

• Bone Marrow Biopsy Procedure

Interventions

DEVICE

Ultrasound-assisted bone marrow biopsy

After the usual landmark technique is performed and the potential site has been marked, the ultrasound machine "fine tunes" the drill site location. The probe is placed over the marked site in the transverse orientation. In this view, the location where the sacrum articulates near the ilium is visualized. The physician then searches for the location of the PSIS at its most superficial location, then the PSIS is centered. The probe is then rocked back and forth to determine the optimal drill angle.The skin is marked at the probe indicators on both long sides. In the sagittal orientation the PSIS is visualized and centered. The skin is then marked at the probe indicators on both long sides. The marker is then used to connect the marks, creating an "X" that marks the desired skin entry point

PROCEDURE

Landmark palpation bone marrow biopsy

The lateral, superior iliac crest is palpated and an attempt is made to follow the course of the posterior iliac crest until the posterior superior iliac spine (PSIS) is palpated. Additionally, the gluteal cleft is visualized indicating the patient midline. The area over the sacrum at midline is then palpated, proceeding laterally until the PSIS can be felt. The skin is marked with a marker at the estimated PSIS and point of entry.

Sponsors & Collaborators

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Devin Madenberg, DO · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-18

Primary Completion

2026-09-01

Completion

2026-12-01

FDA Device

Yes

Countries

• United States

Study Locations