ACP Maxâ„¢ PRP System for Knee Osteoarthritis: A Feasibility Trial (NCT05765266) | Clinical Trial Compass
CompletedNot Applicable
ACP Maxâ„¢ PRP System for Knee Osteoarthritis: A Feasibility Trial
United States45 participantsStarted 2024-05-13
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.