Trial Outcomes & Findings for Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy (NCT NCT03078452)
NCT ID: NCT03078452
Last Updated: 2025-09-08
Results Overview
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
At the time of biopsy
Results posted on
2025-09-08
Participant Flow
Participant milestones
| Measure |
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.
Power drill: Undergo bone marrow biopsy using power drill
|
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.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
Baseline characteristics by cohort
| Measure |
Arm I (Biopsy Using Power Drill)
n=50 Participants
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.
Power drill: Undergo bone marrow biopsy using power drill
|
Arm II (Biopsy Using Jamshidi Needle)
n=50 Participants
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.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=99 Participants
|
63 years
n=107 Participants
|
64.25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Prior Bone Marrow Aspiration & Biopsies (BMA&B) within the last 2 years
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At the time of biopsyBone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Outcome measures
| Measure |
Arm I (Biopsy Using Power Drill)
n=50 Participants
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.
Power drill: Undergo bone marrow biopsy using power drill
|
Arm II (Biopsy Using Jamshidi Needle)
n=50 Participants
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.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle
|
|---|---|---|
|
Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist
|
14 Millimeters
Interval 5.0 to 30.0
|
9.5 Millimeters
Interval 3.0 to 23.0
|
SECONDARY outcome
Timeframe: At the time of, 30 minutes, 1, 3, and 7 days after biopsyThe 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. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain.
Outcome measures
| Measure |
Arm I (Biopsy Using Power Drill)
n=50 Participants
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.
Power drill: Undergo bone marrow biopsy using power drill
|
Arm II (Biopsy Using Jamshidi Needle)
n=50 Participants
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.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle
|
|---|---|---|
|
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
30 minutes
|
.66 score on a scale
Interval 0.0 to 6.0
|
.84 score on a scale
Interval 0.0 to 8.0
|
|
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
1 day after biopsy
|
1.62 score on a scale
Interval 0.0 to 10.0
|
1.62 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
3 days after biopsy
|
.89 score on a scale
Interval 0.0 to 8.0
|
.63 score on a scale
Interval 0.0 to 5.0
|
|
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire
7 days after biopsy
|
.18 score on a scale
Interval 0.0 to 5.0
|
.26 score on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: At the time of biopsyStaff 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.
Outcome measures
| Measure |
Arm I (Biopsy Using Power Drill)
n=50 Participants
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.
Power drill: Undergo bone marrow biopsy using power drill
|
Arm II (Biopsy Using Jamshidi Needle)
n=50 Participants
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.
Jamshidi needle: Undergo bone marrow biopsy using Jamshidi needle
|
|---|---|---|
|
Time Taken by the Procedure Measured in Seconds Using a Stopwatch
|
7 Seconds
Interval 3.0 to 24.0
|
10.5 Seconds
Interval 4.0 to 30.0
|
Adverse Events
Arm I (Biopsy Using Power Drill)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Biopsy Using Jamshidi Needle)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place