NCT05742763 | RECRUITING | Osteoarthritis of the Knee

Detailed Description:

For this 5-year Research Project, the investigators propose to implement a prospective, double-blind, three-arm randomized placebo controlled clinical trial study design across multiple clinic sites in North Carolina and South Carolina. The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of leukocyte poor platelet-rich plasma (LP-PRP) into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate knee osteoarthritis (KOA), and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system. Data collected as part of the PRP-NSAIDs-KOA Trial will be used to: 1) inform the treatment of patients with moderate KOA using the orthobiologic PRP; 2) assess the use of ibuprofen vs acetaminophen vs placebo by serially evaluating pain score outcomes and functionality using standardized and validated pain subscales (Visual Analogue Scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcomes Score (KOOS), and the International Knee Documentation Committee (IKDC) in patients with moderate KOA randomized to three arms; and 3) assess and compare serial changes in composition of whole blood and PRP with the use of ibuprofen vs acetaminophen vs placebo. The investigators will also assess the clinical trial protocol process measures of feasibility, acceptability, and implementation to evaluate and improve multi-site clinical trial delivery at QC Kinetix clinic sites. The central hypothesis of the study is that patients receiving ibuprofen will initially report higher VAS, WOMAC, KOOS, and IKDC pain scores at each 1-month post-treatment follow up, with a return to baseline and progressively lower pain scores at each subsequent follow up visit when compared to patients in the other two arms. The long-term goal of this research study is to build the QC Kinetix workforce clinical research capacity in the conduct of sports and regenerative medicine related multi-site clinical trials and apply for the American Medical Society for Sports Medicine (AMSSM) Foundation Research Grant, the American College of Sports Medicine (ACSM) Research Grant, the Arthritis Society Research Grant, and the AMSSM Collaborative Research Network (CRN) Grant that builds on lessons learned from this research effort. The investigators will successfully achieve the primary research goal of this research study through the following four specific aims Aim #1: During ongoing recruitment and enrollment, the investigators will identify and recruit patients with moderate KOA seen across new and established patients attending QC Kinetix clinic sites (i.e., North and South Carolina). o H1-1: Based on our clinic data, the investigators expect patients on daily NSAIDs to have increased symptoms of pain and reduced function during the washout period of 1 month (all study participants must discontinue all analgesic medications including acetaminophen and NSAIDs) prior to the series of PRP injections. Aim #2. Design and implement a prospective, 5-year double-blinded, three-arm randomized clinical trial study design across multiple QC Kinetix clinic sites (i.e., North and South Carolina) to compare VAS, WOMAC, KOOS, and IKDC pain and function subscale scores at baseline and follow-up visits at months 1, 2, 3, (drug therapy, PRP, and completion of pain subscales); months 4, and 6 (drug therapy and pain subscales) and months 9 and 12 (pain subscales only) post-enrollment and treatment following the initiation of the 3 PRP injections in all three groups \[arm #1-3\] in patients with symptomatic moderate KOA (K-L grade 2 or 3). o H2-1: Patients who receive ibuprofen will initially report higher VAS, WOMAC, KOOS, and IKDC pain scores at each 1-month post-treatment follow up, with a return to baseline and progressively lower pain scores at each subsequent follow up visit when compared to patients in the other two arms. Aim #3: Assess and compare changes in platelet count in the whole blood and PRP of all study participants at each clinic visit. Aim #4: Evaluate process measures (i.e., feasibility, acceptability, and implementation) for clinical trial protocol success between and within all QC Kinetix clinic sites.