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

This study is currently recruiting participants.
Verified December 2016 by Rush University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981394
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
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.
Information provided by (Responsible Party):
Rush University Medical Center
  Purpose
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 Intervention
Musculoskeletal Pain Osteoarthritis Tendinopathy Sprains Strain Procedure: Bone Marrow Aspirate Concentrate Injection

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

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


Estimated Enrollment: 300
Study Start Date: November 2016
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02981394


Locations
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
  More Information

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02981394     History of Changes
Other Study ID Numbers: 16090710-IRB01
First Submitted: December 1, 2016
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Osteoarthritis
Tendinopathy
Musculoskeletal Pain
Sprains and Strains
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms