Clinical Efficacy of a Single-dose of Platelet Rich Plasma in the Management of Early Knee Osteoarthritis: A Randomized Controlled Study With Mri Assessment and Evaluation of Optimal Dose

Abstract

Background: Osteoarthritis (OA) causes substantial physical disability that limits a person's ability to indulge in daily activities. Non-steroidal anti-inflammatory drugs provide only minimal symptomatic benefit and are associated with mild to severe side effects, thus limiting its continuous use. This being the case, new alternate healing strategies with minimal adverse effects are being explored scientifically. In our study we have attempted to evaluate the clinical efficacy of a single dose of Platelet Rich Plasma (PRP) in treating osteoarthritis. Our primary objectives are:i) To optimise the correct dose of PRP preparation to achieve therapeutic relief in knee OAii) To identify the therapeutic efficacy of PRP in selected patients suffering from symptomatic primary knee OA through Randomized Clinical Trials and analyse the possible outcome using MRI analysis.Methods: A randomized, double-blind, 12-month, placebo-controlled study was conducted in 100 outpatients. PRP was prepared from the blood drawn from the subjects and administered intra-articularly guided by ultrasound. The degree of pain was assessed using WOMAC scores, the International Knee Documentation Committee score (IKDC) and six-minute pain free walking distance. The joint space width and articular cartilage thickness was evaluated through x-ray, ultrasonagraphy and MRI.Result: PRP with absolute count of approximately 100 billion platelets brings out significant therapeutic relief. The WOMAC scores showed reduction from 54.7 at baseline to 28.8 at one month, and 29.9 at 3 months showing efficacy of PRP over placebo. Improvement was evident in one month scores of IKDC tests (Baseline- 53.6; 1 month - 76.9) and VAS (Baseline - 5.8; 1 month - 2.46) followed by slight decline at 3, 6-month and one-year scores. Similarly, the pain-free distance covered during a 6-min walk was significantly improved at one month in both the groups (PRP-146 ft.; placebo-122 ft; p value <0.001). No change is seen on MRI and Joint space width.Conclusion: 7 times Concentration and absolute count of 100 billion platelets is crucial in a PRP formulation to be therapeutically effective in alleviating symptoms in moderate knee OA. The results indicate prevention of structural modification in the PRP group and better chondroprotective effects compared to placebo group.Trial Registration: This study has been registered in the US Clinical Trial Registry (U.S. National Library of Medicine) with Trial registration no. 04198467. Date of registration: December 13, 2019. (Retrospectively registered) URL - https://clinicaltrials.gov/ct2/show/NCT04198467?term=04198467&draw=2&rank=1

Profound Properties of Protein Rich Platelet Concentrate Matrices as Novel Multi-Purpose Biological Platforms in Tissue Repair, Regeneration, and Wound Healing

“…Platelet dosing and the PRP bioformulations have been identified as important features in PRP preparations to contribute to analgesic effects [94,95]. Obviously, patients who experience less pain tend to have better outcomes and more effective post-operative rehabilitation results.…”

Modifying Orthobiological PRP Therapies Are Imperative for the Advancement of Treatment Outcomes in Musculoskeletal Pathologies

“…At present, C-PRP formulations have been shown to lead to significant positive patient outcomes when used in numerous pathologies [ 32 , 33 , 34 , 35 , 36 ]. C-PRP is a complex composition of autologous concentrated platelets, with the option of adding or removing other cellular components, in a small volume of plasma, acquired from a fraction of centrifuged peripheral blood.…”

“…Similarly, Berger et al indicated that higher platelet concentrations, prepared from platelet lysate preparations, resulted in more tenocyte proliferation and migration, in a dose dependent manner [ 35 ]. More recently, Bansal and associates injected PRP in patients diagnosed with knee OA with 10 billion TDP [ 33 ]. They observed a consistent clinical effect regarding function, pain, and inflammatory markers after a single injection over a 12-month period.…”

“…However, others reported little to no pain relief [ 48 , 49 ]. Not surprisingly, platelet dosing and the PRP bioformulations have been identified as key features that contribute to consistent painkilling effects [ 33 , 50 ]. Furthermore, the type of injury, specific tissue types, PRP delivery route and application techniques, and the use of platelet activation have been mentioned as variables affecting pain modulation [ 51 ].…”