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NCT05985785NARecruiting

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Rush University Medical Center

Start Date

7/19/2022

Completion Date

3/31/2028

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.

Detailed 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)).

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

OTHER

Autologous bone marrow aspirate concentrate (BMAC)

DRUG

Corticosteroid injections

OTHER

Crossover Autologous bone marrow aspirate concentrate (BMAC)

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Conditions

Osteoarthritis of the Knee

Locations

Rush University Medical Center

Chicago, Illinois 60612

United States