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 range18 Years – 70 Years

SexALL

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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

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