Evaluation of Functional Outcomes of Plasma Rich in Growth Factors (PRGF) in Knee Osteoarthritis: An Unicentric, open Label Double-Blinded Randomized Controlled Trial

Evaluation of Functional Outcomes of Plasma Rich in Growth Factors (PRGF) in Knee Osteoarthritis: An Unicentric, Open Label Double-Blinded Randomized Controlled Trial Rationales/Gaps in Existing Knowledge: Knee osteoarthritis (OA) is a prevalent degenerative joint disorder that leads to pain, reduced mobility, and diminished quality of life. Current treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and surgical interventions. However, these options often provide only temporary relief or have significant side effects. Traditional intra-articular injections, such as corticosteroids or hyaluronic acid, offer symptomatic relief but do not address the underlying degenerative processes. There is a growing need for therapies that not only alleviate symptoms but also promote tissue repair and regeneration. Recently, the use of autologous peripheral blood-derived orthobiologics (APBOs) for the management of knee osteoarthritis (OA) has increased. Platelet-rich plasma (PRP) is the most widely used APBO and is safe and efficacious. However, inferior results were correlated with the absence of a standardized formulation protocol and characterization of the formulation. Inter- and intrapatient variables, such as age, concomitant medications, and comorbidities, have led to questioning the effectiveness of PRP. To overcome this, other APBOs such as plasma rich in growth factors (PRGF) have been explored in patients with knee OA. PRGF is a formulation rich in platelet-derived growth factors that is formulated by incubating whole blood or PRP with an external platelet activator such as calcium chloride. Plasma rich in growth factors (PRGF) has shown potential in enhancing tissue healing in various clinical settings, but its safety and efficacy in knee OA management remain inadequately studied. Novelty: PRGF represents a novel approach for managing knee osteoarthritis by leveraging the natural healing processes of the body. Unlike other intra-articular treatments, PRGF is derived from the patient’s blood and is concentrated with growth factors that can potentially stimulate tissue regeneration and reduce inflammation. The use of PRGF could offer the dual benefit of pain relief and structural improvement of the joint. This study will contribute to the emerging field of regenerative medicine by providing clinical evidence on the use of PRGF for knee OA, an area where limited data are currently available. Methods: This will be a double-blind, randomized, controlled clinical trial. Participants diagnosed with knee osteoarthritis will be randomly assigned to receive either PRGF or PRP injections. PRGF and PRP will be prepared using the patient’s blood, processed to concentrate growth factors, and injected into the knee joint. Outcomes will be measured at baseline, 1, 3, 6, and 12 months post-treatment. The primary outcome will be the efficacy (joint function). The secondary outcomes will include pain, patient satisfaction, safety (adverse events), and imaging studies (MRI) to assess cartilage repair. Expected Outcome: This study is expected to demonstrate that PRGF is an effective treatment option for knee osteoarthritis with minimal adverse effects. It is anticipated that PRGF will show significant efficacy in reducing pain and improving joint function compared with PRP. Additionally, PRGF may demonstrate potential in promoting cartilage repair and slowing the progression of osteoarthritis.