RecruitingNot ApplicableNCT05985785

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Sponsor

Rush University Medical Center

Enrollment

100 participants

Start Date

Jul 19, 2022

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis of the knee

Summary

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

Patients between the ages of 18-70
Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
-day average pain score of at least 4 on VAS scale

Exclusion Criteria3

Systemic diseases (Diabetes, malignancies, infections, etc.)
Post-traumatic arthritis
Patient had intra-articular injection on affected knee in last three months

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAutologous bone marrow aspirate concentrate (BMAC)

Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.

DRUGCorticosteroid injections

Current standard of treatment for OA of the knee is corticosteroid injection.

OTHERCrossover Autologous bone marrow aspirate concentrate (BMAC)

Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)