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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02981394
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Musculoskeletal Pain Osteoarthritis Tendinopathy Sprains Strain Procedure: Bone Marrow Aspirate Concentrate Injection

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Study Start Date : November 2016
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
BMAC Group
Intervention Group
Procedure: 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.

Primary Outcome Measures :
  1. WOMAC Score [ Time Frame: 5 years ]
    Pain and Function Score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a musculoskeletal condition amenable to BMAC or PRP treatment will be enrolled upon registration for the selected procedure. Proper counseling regarding the selected procedure and alternatives will be done prior to enrollment. Patients with contraindications for the procedure will not undergo the procedure and therefore will not be enrolled. The study will be non-randomized; therefore, patient selection will be based upon patient request for the procedure after proper counseling. Counseling regarding cost of each procedure will also be provided. All costs for the procedure will be the responsibility of the patient. Proper documentation will also be signed by the patient indicating that procedure is elective and PRP/BMAC injections will not be billed to their insurance carriers. Upon enrollment, patients will be consented for the procedure and longitudinal data collection.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02981394

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United States, Illinois
Midwest Orthopeadics at Rush Recruiting
Chicago, Illinois, United States, 60612
Contact: Jeremy A Alland, MD    312-432-2434      
Sponsors and Collaborators
Rush University Medical Center

Additional Information:

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Responsible Party: Rush University Medical Center Identifier: NCT02981394    
Other Study ID Numbers: 16090710-IRB01
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Musculoskeletal Pain
Musculoskeletal Diseases
Wounds and Injuries
Muscular Diseases
Tendon Injuries
Neurologic Manifestations
Signs and Symptoms