Rush University Medical Center
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.
Osteoarthritis of the Knee
Autologous bone marrow aspirate concentrate (BMAC)
Corticosteroid injections
Crossover Autologous bone marrow aspirate concentrate (BMAC)
NA
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)).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 100 participants |
| Masking : | SINGLE |
| Primary Purpose : | OTHER |
| Official Title : | Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial |
| Actual Study Start Date : | 2022-07-19 |
| Estimated Primary Completion Date : | 2026-12-31 |
| Estimated Study Completion Date : | 2027-03-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Rush University Medical Center
Chicago, Illinois, United States, 60612