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NCT02981394 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02981394
Other study ID # 16090710-IRB01
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2016
Est. completion date January 2021

Study information
Verified date May 2021
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Midwest Orthopeadics at Rush Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary WOMAC Score Pain and Function Score 5 years
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