Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions

NCT ID: NCT02981394

Last Updated: 2021-05-27

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-01-31

Brief Summary

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The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse. The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including osteoarthritis, tendinopathy and injuries to ligaments, tendons and muscles.

Detailed Description

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Conditions

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Musculoskeletal Pain Osteoarthritis Tendinopathy Sprains Strain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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BMAC Group

Intervention Group

Bone Marrow Aspirate Concentrate Injection

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Musculoskeletal Condition that is able to undergo an injection
* Patient requests the procedure and enrolls with agreement to pay for the procedure

Exclusion Criteria

* Active Cancer
* Allergies to local anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Midwest Orthopeadics at Rush

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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16090710-IRB01

Identifier Type: -

Identifier Source: org_study_id

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