Table 1.

Inclusion and Exclusion Criteria ^a

Inclusion Criteria
▪ Age of 25-75 years ▪ Body mass index <40 kg/m2 ▪ Symptomatic knee OA (primary and posttraumatic) ▪ Radiographic evidence of OA in the target knee (Kellgren-Lawrence grades 1-4) ▪ Continued pain in the target knee despite at least 6 weeks of one of the following nonoperative treatment options: activity modification, weight loss, physical therapy, or NSAID/acetaminophen ▪ KOOS–Pain subscore of 20-65 ▪ Working knowledge of the English language (to be able to complete all outcome measures) ▪ Ability to attend all follow-up appointments
Exclusion Criteria
▪ Isolated patellofemoral OA ▪ 3+ effusion in the target knee (stroke test grading system) ▪ Valgus or varus deformities >10° ▪ Steroid injection in the target knee in the past 3 months ▪ Viscosupplementation in the target knee in the past 6 months ▪ PRP in the target knee in the past 1 year ▪ Other cellular/orthobiologic treatment in the index knee (bone marrow, amniotic suspension, etc) at any previous time ▪ Participation in any experimental device or drug study within 1 year before the screening visit ▪ Oral or intramuscular steroids for the past 3 months ▪ Medical condition that may affect outcomes of the procedure, including anemia, thrombocytopenia, bleeding disorders, systemic inflammatory disorders (rheumatoid arthritis, lupus, etc), diabetes, history of cancer (other than nonmelanoma skin malignancies), anticoagulant therapy (that could not be held 1 week before the procedure), and immunosuppression ▪ Previous cartilage repair procedure on the injured cartilage surface ▪ Previous surgery in the target knee within the past 1 year ▪ Any degree of cognitive impairment ▪ Symptomatic OA in either hip ▪ Symptomatic OA in the contralateral knee ▪ Pregnancy, lactation, or intent to become pregnant during the treatment period ▪ History of gout ▪ History of infections or current infections in the affected joint ▪ Smoking

^a KOOS, Knee injury and Osteoarthritis Outcome Score; NSAID, nonsteroidal anti-inflammatory drug; OA, osteoarthritis; PRP, platelet-rich plasma.