Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
NCT ID: NCT02981394
Last Updated: 2021-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2016-11-30
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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BMAC Group
Intervention Group
Bone Marrow Aspirate Concentrate Injection
BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.
Interventions
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Bone Marrow Aspirate Concentrate Injection
BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.
Eligibility Criteria
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Inclusion Criteria
* Patient requests the procedure and enrolls with agreement to pay for the procedure
Exclusion Criteria
* Allergies to local anesthesia
18 Years
90 Years
ALL
Yes
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Locations
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Midwest Orthopeadics at Rush
Chicago, Illinois, United States
Countries
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Other Identifiers
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16090710-IRB01
Identifier Type: -
Identifier Source: org_study_id
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