NCT02981394

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Musculoskeletal Pain
• Osteoarthritis
• Tendinopathy
• Sprains Strain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2016-12-05
• Last updated: 2021-05-27

Locations

1 site across 1 country: United States