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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
100
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.
Current standard of treatment for OA of the knee is corticosteroid injection.
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)
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGVisual 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.
Time frame: 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.
Time frame: 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)
Time frame: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)
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