ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial

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.

Inclusion criteria

• Subject voluntarily decides to participate and signs the consent form.
• Subject is ≥ 18 to 75 years of age.
• Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications.
• Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening.
• Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities.
• Subject consents to a washout period of NSAIDs and analgesics 7 days before each study visit (except low-dose aspirin for prevention of cardiovascular disease).
• Subject has a Body Mass Index ≤ 35 kg/m2

Exclusion criteria

• Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale.
• Subject has clinically 3+ effusion of the target knee (stroke test grading system).
• Subject has significant (> 10°) valgus or varus deformities as evidenced by standard of care x-ray.
• Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening.
• Subject did not achieve initial pain relief from prior corticosteroid injections.
• Subject has received an IA injection of HA in the target knee within 6 months prior to screening.
• Subject has received an IA injection of PRP in the target knee at any time prior to screening.
• Subject has a history of coagulopathy.
• Subject has joint pain reflected by a VAS score of > 35 mm out of 100 mm scale in the contralateral knee at the time of screening.
• Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months.
• Subject has an inflammatory disease of either knee other than OA.
• Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome.
• Subject with a positive pregnancy test or breastfeeding.
• Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months.
• Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives.
• Subject has rheumatoid arthritis or gout.
• Subject has an infection at the affected joint.
• Subject has a history of major trauma to the target knee within one year.
• Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
• Subject requires pain management therapy not related to the target knee (with the exception of acetaminophen).
• Subject has a known hypersensitivity to Depo-Medrol and its constituents.