Bone Marrow Biopsy ProcedureLUMPNCT05258357
Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study
A study testing Ultrasound-assisted bone marrow biopsy and Landmark palpation bone marrow biopsy in people with Bone Marrow Biopsy Procedure, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Biopsy Procedure
- What is being tested?
- Ultrasound-assisted bone marrow biopsy and Landmark palpation bone marrow biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 12 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
2.1 Hypothesis The Investigators will be working under the overarching hypothesis that using ultrasound to locate the PSIS and determine the appropriate drilling angle will provide better outcomes and disease diagnosis for patients undergoing the bone marrow biopsy procedure.
2.2 Primary Objective • Determine whether incorporating ultrasound into a routine bone marrow biopsy improves the adequacy of core sample for diagnosis.
2.3 Secondary Objectives
- Determine whether incorporating ultrasound into a routine bone marrow biopsy improves the adequacy of aspirate smears.
- Determine whether incorporating ultrasound into a routine bone marrow biopsy improves patient pain assessment.
- Establish a correlation between number of drill attempts and patient pain.
- Examine whether the ultrasound-assisted bone marrow biopsy procedure reduces drill attempts.
- Determine if ultrasound-assisted bone marrow biopsy reduces patient risk, as measured by the number of complications post-procedure.
2.4 Primary Endpoint
- Adequacy of core samples for diagnosis between landmark and ultrasound-assisted arms: The proportion of adequate, suboptimal, and inadequate bone marrow biopsy samples, as measured by the overall length of evaluable marrow space using hematoxylin and eosin (H\&E) stained slides, will be compared between the landmark and ultrasound-assisted cohorts. Cores containing ≥1.5 cm of evaluable marrow space will be considered adequate, 0.5-1.5 cm suboptimal, and <0.5 cm inadequate.
2.5 Secondary Endpoints
- Adequacy of aspirate smears between landmark and ultrasound-assisted arms: The proportion of adequate, suboptimal, and inadequate aspirate smears, as measured by the presence of aggregate marrow spicules and overt presence of marrow cells, will be compared between the landmark and ultrasound-assisted cohorts. Aspirate smears with at least one 200x field in aggregate marrow spicules will be considered adequate. Those with marrow spicules but less than one 200x field in aggregate, or those without marrow spicules but with overt presence of marrow cells on initial scanning, will be considered suboptimal. Those without marrow spicules and without overt presence of marrow cells on initial scanning will be considered inadequate.
- Patient pain assessment between landmark and ultrasound-assisted arms: The proportion of patients with a pain score of seven or more, determined 12 to 24 hour post-procedure, will be compared between the landmark and ultrasound-assisted cohorts. Pain assessment will be scored for each patient using the 0-10 point visual analog scale.
- Correlation between number of drill attempts and patient pain: A correlation coefficient (Pearson's or Spearman's) will be determined by using the number of drill attempts and the pain scores collected during a 12- to 24-hour post-procedure window for all patients regardless of the arm. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure. Patient pain assessment will be scored using the 0-10 point visual analog scale.
- Number of drill attempts between landmark and ultrasound-assisted arms: The mean number of drill attempts needed will be compared between the landmark and ultrasound-assisted cohorts. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure.
- Number of complications between landmark and ultrasound-assisted arms: The mean number of complications within +30 days post-procedure will be compared between the landmark and ultrasound-assisted cohorts. The specific type and number of complications will be recorded and tabulated, respectively, for each patient within +30 days post-procedure.
- Conditions
- Bone Marrow Biopsy Procedure
- Being tested
- Ultrasound-assisted bone marrow biopsy, Landmark palpation bone marrow biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted bone marrow biopsyDevice
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
Landmark palpation bone marrow biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Landmark | Active comparator | For a landmark bone marrow biopsy procedure, the patient is first positioned either prone or lateral decubitus. 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. Receives: Procedure: Landmark palpation bone marrow biopsy |
| Ultrasound-Assisted | Experimental | After the usual landmark technique is performed and the potential site has been marked, procedure team physician will use the ultrasound machine to "fine tune" the drill site location. Receives: Device: Ultrasound-assisted bone marrow biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core adequacy
The proportion of adequate, suboptimal, and inadequate bone marrow biopsy samples, as measured by the overall length of evaluable marrow space using hematoxylin and eosin (H\&E) stained slides, will be compared between the landmark and ultrasound-assisted cohorts. Cores containing ≥1.5 cm of evaluable marrow space will be considered adequate, 0.5-1.5 cm suboptimal, and <0.5 cm inadequate
Measured: Assessed at the end of the study, estimated to be at 2 years. Samples will be analyzed by a pathologist once all samples from 100 participants are obtained.
Secondary outcomes (5)
Aspirate adequacy
The proportion of adequate, suboptimal, and inadequate aspirate smears, as measured by the presence of aggregate marrow spicules and overt presence of marrow cells, will be compared between the landmark and ultrasound-assisted cohorts. Aspirate smears with at least one 200x field in aggregate marrow spicules will be considered adequate. Those with marrow spicules but less than one 200x field in aggregate, or those without marrow spicules but with overt presence of marrow cells on initial scanning, will be considered suboptimal. Those without marrow spicules and without overt presence of marrow cells on initial scanning will be considered inadequate.
Measured: Assessed at the end of the study, estimated to be at 2 years. Samples will be analyzed by a pathologist once all samples from 100 participants are obtained.
Procedural Pain via visual analog scale
The proportion of patients with a pain score of seven or more, determined 12 to 24 hour post-procedure, will be compared between the landmark and ultrasound-assisted cohorts. Pain assessment will be scored for each patient using the 0-10 point visual analog scale.
Measured: Determined immediately following procedure and 12-24 hours after, for each participant.
Drill attempts and pain correlation
A correlation coefficient (Pearson's or Spearman's) will be determined by using the number of drill attempts and the pain scores collected during a 12- to 24-hour post-procedure window for all patients regardless of the arm. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure. Patient pain assessment will be scored using the 0-10 point visual analog scale.
Measured: Assessed at the end of the study, estimated to be at 2 years.
Mean Number of Drill attempts
The mean number of drill attempts needed to successfully complete the procedure will be compared between the landmark and ultrasound-assisted cohorts. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure.
Measured: Determined immediately following procedure for each participant.
Complications
- Determine if ultrasound-assisted bone marrow biopsy reduces patient risk, as measured by the number of complications post-procedure.
Measured: Determined 30 days after the procedure, for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start18 May 2022
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow Biopsy ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devin Madenberg, Medical College of Wisconsin
- Investigators
- Devin Madenberg, DO, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258357
- Sponsor's protocol ID
- MCW Lump Study
- Acronym
- LUMP
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2022
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD will be viewable in our secured excel data spreadsheet
Publications
Islam A. Ultrasound: a new tool for precisely locating posterior iliac crests to obtain adequate bone marrow trephine biopsy specimen. J Clin Pathol. 2013 Aug;66(8):718-20. doi: 10.1136/jclinpath-2013-201463. Epub 2013 Mar 14.
PubMed 23493477Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
PubMed 23532866Cho YC, Koo DH, Oh SK, Jeong WJ, Lee WS, You YH, Ryu S, Lee JW, Kim SW, Yoo IS. Comparison of ultrasound-assisted lumbar puncture with lumbar puncture using palpation of landmarks in aged patients in an emergency center. J Korean Soc Emerg Med. 2009; 20(3):304-309.
Mofidi M, Mohammadi M, Saidi H, Kianmehr N, Ghasemi A, Hafezimoghadam P, Rezai M. Ultrasound guided lumbar puncture in emergency department: Time saving and less complications. J Res Med Sci. 2013 Apr;18(4):303-7.
PubMed 24124427Edwards C, Leira EC, Gonzalez-Alegre P. Residency training: a failed lumbar puncture is more about obesity than lack of ability. Neurology. 2015 Mar 10;84(10):e69-72. doi: 10.1212/WNL.0000000000001335.
PubMed 25754807Degen C, Christen S, Rovo A, Gratwohl A. Bone marrow examination: a prospective survey on factors associated with pain. Ann Hematol. 2010 Jun;89(6):619-24. doi: 10.1007/s00277-010-0934-0. Epub 2010 Mar 24.
PubMed 20333524Vanhelleputte P, Nijs K, Delforge M, Evers G, Vanderschueren S. Pain during bone marrow aspiration: prevalence and prevention. J Pain Symptom Manage. 2003 Sep;26(3):860-6. doi: 10.1016/s0885-3924(03)00312-9.
PubMed 12967736Kuball J, Schüz J, Gamm H, Weber M. Bone marrow punctures and pain. Acute Pain. 2004; 6(1):9-14.
Liden Y, Landgren O, Arner S, Sjolund KF, Johansson E. Procedure-related pain among adult patients with hematologic malignancies. Acta Anaesthesiol Scand. 2009 Mar;53(3):354-63. doi: 10.1111/j.1399-6576.2008.01874.x.
PubMed 19243321Brestoff JR, Toland A, Afaneh K, Qavi AJ, Press B, Westervelt P, Kreisel F, Hassan A. Bone Marrow Biopsy Needle Type Affects Core Biopsy Specimen Length and Quality and Aspirate Hemodilution. Am J Clin Pathol. 2019 Jan 7;151(2):185-193. doi: 10.1093/ajcp/aqy126.
PubMed 30307478Marinelli LM, Fang H, Howard MT, Hanson CA, Haack JJ, Eick EA, Allen RJ, Ruffridge DE, Byrne CM, King RL. Bone Marrow Biopsy Operator Experience and Impact on Aspirate, Biopsy, and Ancillary Testing Quality. Mayo Clin Proc Innov Qual Outcomes. 2018 Aug 1;2(3):241-247. doi: 10.1016/j.mayocpiqo.2018.06.007. eCollection 2018 Sep.
PubMed 30225457
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study
- ClinicalTrials.gov ID
- NCT05258357
- Acronym / sponsor ID
- LUMP / MCW Lump Study
- Conditions
- Bone Marrow Biopsy Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
2.1 Hypothesis The Investigators will be working under the overarching hypothesis that using ultrasound to locate the PSIS and determine the appropriate drilling angle will provide better outcomes and disease diagnosis for patients undergoing the bone marrow biopsy procedure.
2.2 Primary Objective • Determine whether incorporating ultrasound into a routine bone marrow biopsy improves the adequacy of core sample for diagnosis.
2.3 Secondary Objectives
- Determine whether incorporating ultrasound into a routine bone marrow biopsy improves the adequacy of aspirate smears.
- Determine whether incorporating ultrasound into a routine bone marrow biopsy improves patient pain assessment.
- Establish a correlation between number of drill attempts and patient pain.
- Examine whether the ultrasound-assisted bone marrow biopsy procedure reduces drill attempts.
- Determine if ultrasound-assisted bone marrow biopsy reduces patient risk, as measured by the number of complications post-procedure.
2.4 Primary Endpoint
- Adequacy of core samples for diagnosis between landmark and ultrasound-assisted arms: The proportion of adequate, suboptimal, and inadequate bone marrow biopsy samples, as measured by the overall length of evaluable marrow space using hematoxylin and eosin (H\&E) stained slides, will be compared between the landmark and ultrasound-assisted cohorts. Cores containing ≥1.5 cm of evaluable marrow space will be considered adequate, 0.5-1.5 cm suboptimal, and <0.5 cm inadequate.
2.5 Secondary Endpoints
- Adequacy of aspirate smears between landmark and ultrasound-assisted arms: The proportion of adequate, suboptimal, and inadequate aspirate smears, as measured by the presence of aggregate marrow spicules and overt presence of marrow cells, will be compared between the landmark and ultrasound-assisted cohorts. Aspirate smears with at least one 200x field in aggregate marrow spicules will be considered adequate. Those with marrow spicules but less than one 200x field in aggregate, or those without marrow spicules but with overt presence of marrow cells on initial scanning, will be considered suboptimal. Those without marrow spicules and without overt presence of marrow cells on initial scanning will be considered inadequate.
- Patient pain assessment between landmark and ultrasound-assisted arms: The proportion of patients with a pain score of seven or more, determined 12 to 24 hour post-procedure, will be compared between the landmark and ultrasound-assisted cohorts. Pain assessment will be scored for each patient using the 0-10 point visual analog scale.
- Correlation between number of drill attempts and patient pain: A correlation coefficient (Pearson's or Spearman's) will be determined by using the number of drill attempts and the pain scores collected during a 12- to 24-hour post-procedure window for all patients regardless of the arm. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure. Patient pain assessment will be scored using the 0-10 point visual analog scale.
- Number of drill attempts between landmark and ultrasound-assisted arms: The mean number of drill attempts needed will be compared between the landmark and ultrasound-assisted cohorts. The number of drill attempts needed to obtain bone marrow for each patient will be recorded immediately following the procedure.
- Number of complications between landmark and ultrasound-assisted arms: The mean number of complications within +30 days post-procedure will be compared between the landmark and ultrasound-assisted cohorts. The specific type and number of complications will be recorded and tabulated, respectively, for each patient within +30 days post-procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark | Active comparator | Procedure: Landmark palpation bone marrow biopsyFor a landmark bone marrow biopsy procedure, the patient is first positioned either prone or lateral decubitus. 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. |
| Ultrasound-Assisted | Experimental | Device: Ultrasound-assisted bone marrow biopsyAfter the usual landmark technique is performed and the potential site has been marked, procedure team physician will use the ultrasound machine to "fine tune" the drill site location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-assisted bone marrow biopsyAfter 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 | Device | Ultrasound-Assisted |
| Landmark palpation bone marrow biopsyThe 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. | Procedure or surgery | Landmark |
Primary outcome
Core adequacy
Time frame: Assessed at the end of the study, estimated to be at 2 years. Samples will be analyzed by a pathologist once all samples from 100 participants are obtained.
The proportion of adequate, suboptimal, and inadequate bone marrow biopsy samples, as measured by the overall length of evaluable marrow space using hematoxylin and eosin (H\&E) stained slides, will be compared between the landmark and ultrasound-assisted cohorts. Cores containing ≥1.5 cm of evaluable marrow space will be considered adequate, 0.5-1.5 cm suboptimal, and <0.5 cm inadequate
5 secondary outcomes
Aspirate adequacy
Time frame: Assessed at the end of the study, estimated to be at 2 years. Samples will be analyzed by a pathologist once all samples from 100 participants are obtained.
Procedural Pain via visual analog scale
Time frame: Determined immediately following procedure and 12-24 hours after, for each participant.
Drill attempts and pain correlation
Time frame: Assessed at the end of the study, estimated to be at 2 years.
Mean Number of Drill attempts
Time frame: Determined immediately following procedure for each participant.
Complications
Time frame: Determined 30 days after the procedure, for each participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 23493477Islam A. Ultrasound: a new tool for precisely locating posterior iliac crests to obtain adequate bone marrow trephine biopsy specimen. J Clin Pathol. 2013 Aug;66(8):718-20. doi: 10.1136/jclinpath-2013-201463. Epub 2013 Mar 14.
- Background: PubMed 23532866Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
- BackgroundCho YC, Koo DH, Oh SK, Jeong WJ, Lee WS, You YH, Ryu S, Lee JW, Kim SW, Yoo IS. Comparison of ultrasound-assisted lumbar puncture with lumbar puncture using palpation of landmarks in aged patients in an emergency center. J Korean Soc Emerg Med. 2009; 20(3):304-309.
- Background: PubMed 24124427Mofidi M, Mohammadi M, Saidi H, Kianmehr N, Ghasemi A, Hafezimoghadam P, Rezai M. Ultrasound guided lumbar puncture in emergency department: Time saving and less complications. J Res Med Sci. 2013 Apr;18(4):303-7.
- Background: PubMed 25754807Edwards C, Leira EC, Gonzalez-Alegre P. Residency training: a failed lumbar puncture is more about obesity than lack of ability. Neurology. 2015 Mar 10;84(10):e69-72. doi: 10.1212/WNL.0000000000001335.
- Background: PubMed 20333524Degen C, Christen S, Rovo A, Gratwohl A. Bone marrow examination: a prospective survey on factors associated with pain. Ann Hematol. 2010 Jun;89(6):619-24. doi: 10.1007/s00277-010-0934-0. Epub 2010 Mar 24.
- Background: PubMed 12967736Vanhelleputte P, Nijs K, Delforge M, Evers G, Vanderschueren S. Pain during bone marrow aspiration: prevalence and prevention. J Pain Symptom Manage. 2003 Sep;26(3):860-6. doi: 10.1016/s0885-3924(03)00312-9.
- BackgroundKuball J, Schüz J, Gamm H, Weber M. Bone marrow punctures and pain. Acute Pain. 2004; 6(1):9-14.
- Background: PubMed 19243321Liden Y, Landgren O, Arner S, Sjolund KF, Johansson E. Procedure-related pain among adult patients with hematologic malignancies. Acta Anaesthesiol Scand. 2009 Mar;53(3):354-63. doi: 10.1111/j.1399-6576.2008.01874.x.
- Background: PubMed 30307478Brestoff JR, Toland A, Afaneh K, Qavi AJ, Press B, Westervelt P, Kreisel F, Hassan A. Bone Marrow Biopsy Needle Type Affects Core Biopsy Specimen Length and Quality and Aspirate Hemodilution. Am J Clin Pathol. 2019 Jan 7;151(2):185-193. doi: 10.1093/ajcp/aqy126.
- Background: PubMed 30225457Marinelli LM, Fang H, Howard MT, Hanson CA, Haack JJ, Eick EA, Allen RJ, Ruffridge DE, Byrne CM, King RL. Bone Marrow Biopsy Operator Experience and Impact on Aspirate, Biopsy, and Ancillary Testing Quality. Mayo Clin Proc Innov Qual Outcomes. 2018 Aug 1;2(3):241-247. doi: 10.1016/j.mayocpiqo.2018.06.007. eCollection 2018 Sep.
- Individual participant dataSharing planned: Yes. All collected IPD will be viewable in our secured excel data spreadsheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devin Madenberg, DO principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-assisted bone marrow biopsy and Landmark palpation bone marrow biopsy in people with Bone Marrow Biopsy Procedure, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core adequacy (time frame: Assessed at the end of the study, estimated to be at 2 years. Samples will be analyzed by a pathologist once all samples from 100 participants are obtained.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258357, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.