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Clinical Trial

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study

NCT: NCT05258357 · COMPLETED

NCT IDNCT05258357
StatusCOMPLETED
Start Date2022-05-18
Completion2026-05-12
SponsorMedical College of Wisconsin (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study?

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study is a clinical trial registered under NCT05258357. Current status: COMPLETED.

What is the status of NCT05258357?

The current status of NCT05258357 (Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study) is: COMPLETED.

When did Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study start?

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study started on 2022-05-18.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.