Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Study Overview
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Brief Summary
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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
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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)).

Official Title
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Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Other: Autologous bone marrow aspirate concentrate (BMAC)
* Drug: Corticosteroid injections
* Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections<br>Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. Autologous means that the subject is receiving back their own cells that were collected. | Other: Autologous bone marrow aspirate concentrate (BMAC)<br>* 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.<br>|
| Active Comparator: Corticosteroid injection<br>Corticosteroid injection group (ARM 2) will receive a sham incision. | Drug: Corticosteroid injections<br>* Current standard of treatment for OA of the knee is corticosteroid injection.<br>|
| Other: Crossover Group<br>Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3). | Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) for pain | 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. | Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1) | 
| Intermittent and Constant Osteoarthritis Pain (ICOAP) | 13 items survey that assess two forms of pain reported by people with osteoarthritis: intermittent and constant pain. | Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1) | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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) | Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1) |