RecruitingNot Applicable

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

United States100 participantsStarted 2022-07-19

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analogue scale (VAS) for pain

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Intermittent and Constant Osteoarthritis Pain (ICOAP)

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Trial details

NCT IDNCT05985785

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Carla M. Edwards, PhD

312-563-5735 carla_edwards@rush.edu

View on ClinicalTrials.gov More Osteoarthritis of the Knee trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual analogue scale (VAS) for pain

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Intermittent and Constant Osteoarthritis Pain (ICOAP)

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Timeframe: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)