Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study

Completed · Not applicable

Conditions studied: Bone Marrow Biopsy Procedure

In brief

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.

Key facts

Study ID

NCT05258357

Run by

Medical College of Wisconsin

People needed

100

Starts

2022-05-18

Expected to finish

2026-05-12

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inpatient at Froedtert \& MCW Froedtert Hospital ≥18 years old.
• Inpatient at Froedtert \& MCW Froedtert Hospital requiring a bone marrow biopsy performed by the Medicine Bedside Procedure Team.
• Bone marrow biopsy is being performed for the explicit purpose of hematology/oncology assessment.
• Personally or via power of attorney (POA) in-person consent to the bone marrow biopsy procedure.
• Provide written informed consent to be on the study.
• English speaking

You may not qualify if…

• Inpatient at Froedtert \& MCW Froedtert Hospital <18 years old.
• Inpatient having no indication for bone marrow biopsy.
• BMI ≥ 40.
• Inpatient that does not consent to the procedure themselves or have a POA that does not consent to the procedure.

Where it is running

• Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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