This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).
All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml.
The Center for Clinical Research
Winston-Salem, North Carolina, United States
AMR Knoxville
Knoxville, Tennessee, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Adverse Events
A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months.
Time frame: 6 months
Adverse Events
Analysis of the frequency and severity of all adverse events for the investigational group at 12 months.
Time frame: 12 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale
A 24-item questionnaire with 3 subscales measuring pain, stiffness, function and total scores.
Time frame: Day 10, 6 weeks, 3, 6, 9 and 12 Months
Medication Usage
Medication Usage related to knee pain.
Time frame: Day 10, 6 weeks, 3, 6, 9 and 12 months
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