PRP vs Hyaluronic Acid Injections for Knee Osteoarthritis Treatment
platelet-rich plasma
+ durolane
Treatment Study
Summary
Study start date: December 11, 2012
Actual date on which the first participant was enrolled.This study focuses on treating knee osteoarthritis, a condition that's becoming more common due to an aging population and increased sports participation. The goal is to reduce pain and improve knee function, helping patients maintain their daily activities. Currently, treatments include painkillers, non-steroidal anti-inflammatory drugs (NSAIDs), and if these aren't effective, intra-articular injections. One such injection uses hyaluronic acid, recommended by the American College of Rheumatology and the European League against Rheumatism. However, its effectiveness varies and often doesn't last beyond six months. Platelet-rich plasma (PRP) is another option being explored. It's a natural concentrate of growth factors that could stimulate cartilage repair, potentially offering an alternative to hyaluronic acid for knee osteoarthritis that doesn't respond to oral drugs. The study involves 80 patients with symptomatic knee osteoarthritis. It's a comparative, single-center, prospective, randomized, double-blind study, meaning neither the patients nor the researchers know who receives which treatment. The two treatments being compared are intra-articular injections of either platelet-rich plasma (PRP) or hyaluronic acid. The study's main outcome is to evaluate if PRP is not inferior to hyaluronic acid in improving knee function. This is measured using the WOMAC functional score, which assesses changes in knee function before and three months after treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.58 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Males and females between 20 to 75 years of age 2. Symptomatic knee arthritis 3. Axial deformity of the lower limb equal or lower than 5° 4. BMI between 20 to 30 5. Written informed consent, signed by patient or legal representative (if patient unable to sign). 6. HB > 10g/dl 7. Negative pregnancy test Exclusion Criteria: Axial deformity of the lower limb over 5° Knee instability BMI < 20 or > 30 Thrombocytopenia < 150 G/L Thrombopathy Anaemia: HB < 10g/dl Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion Intra articular knee injection of corticosteroid or completed more than 8 weeks before inclusion Intra articular knee injection of hyaluronic or completed more than 24 weeks before inclusion NSAI treatment completed more than 2 weeks before inclusion Fever or recent disease Auto immune disease Inflammatory Arthritis Immune deficit Infectious disease Pregnancy Patient under guardianship. Participation in another investigational trial within this trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Assistance Publique Hopitaux de Marseille
Marseille, FranceOpen Assistance Publique Hopitaux de Marseille in Google Maps