Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Rush

Status: Enrolling

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Corticosteroid injections; Other: Autologous bone marrow aspirate concentrate (BMAC); Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05985785

21052504

Details and patient eligibility

About

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.

Full description

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 7-day average pain score of at least 4 on VAS scale

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections

Experimental group

Description:

Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. "Autologous" means that the subject is receiving back their own cells that were collected.

Treatment:

Other: Autologous bone marrow aspirate concentrate (BMAC)

Corticosteroid injection

Active Comparator group

Description:

Corticosteroid injection group (ARM 2) will receive a sham incision.

Treatment:

Drug: Corticosteroid injections

Crossover Group

Other group

Description:

Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).

Treatment:

Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)