NCT05985785 · Rush University Medical Center
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
(BMAC)
What this study is about
forward-looking single-masked (study participant will be masked), randomly assigned controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.
View original scientific description
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.
Interventions
OTHER
Autologous 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.
DRUG
Corticosteroid injections
Current standard of treatment for OA of the knee is corticosteroid injection.
OTHER
Crossover 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)
Primary outcome measures
Visual analogue scale (VAS) for pain
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Intermittent and Constant Osteoarthritis Pain (ICOAP)
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations