Completed

PRP vs Hyaluronic Acid Injections for Knee Osteoarthritis Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

platelet-rich plasma

+ durolane

Drug
Who is being recruted

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorAssistance Publique Hopitaux De Marseille
Last updated: April 21, 2023
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorAssistance Publique Hopitaux De Marseille
Last updated: April 21, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study 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
CompletedOne Study Center