Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07016672

Efficacy of Therapy With PRP Injections Versus HA in Patients With Advanced Grade of GONArthrosis

Led by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated on 2026-04-14

150

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Lead Sponsor

F

Fondation Apicil

Collaborating Sponsor

AI-Summary

What this Trial Is About

Gonarthrosis is a chronic pathology affecting the knee joint and tissues. It is characterized by progressive degeneration of articular cartilage, bone and surrounding structures. Diagnosis is based on clinical, biological and radiological criteria. When knee osteoarthritis becomes symptomatic, it leads to pain associated with stiffness and functional discomfort, impacting on patients' quality of life. Patients become sedentary and isolated, which has cardiovascular and psychological consequences, with a proven excess mortality rate. To date, there are no curative treatments for gonarthrosis. Available treatments are generally aimed at relieving pain, improving joint function and slowing disease progression. Therapeutic approaches most often combine non-pharmacological treatments such as dietary measures, regular physical activity and therapeutic education, with pharmacological treatments: paracetamol, non-steroidal anti-inflammatory drugs, opioids, intra-articular injections of corticosteroids, hyaluronic acid (HA), Platelet Rich Plasma (PRP)... If these are ineffective, particularly in advanced stages (grades III-IV), then surgery for prosthesis is necessary. However, surgery is not an option for all patients, particularly those with co-morbidities, the elderly or those who refuse it. The osteoarthritis section of the French rheumatology society has drawn up recommendations, with a view to positioning these treatments, standardizing practices and improving the management of gonarthrosis patients in France. These point out that further studies are needed to validate the efficacy of certain treatments, notably intra-articular PRP injections, which are nevertheless widely used in current practice and defended by a consensus of French experts published in 2021. Indeed, the results of several therapeutic trials and meta-analyses already published show that its efficacy is often superior to that of HA, particularly in terms of symptom improvement and over a longer duration. In order to make the case for their use to learned societies, literature data must be enriched, particularly with regard to advanced stages of gonarthrosis, i.e. stages III-IV, which are the most painful. The aim is to propose an effective treatment to relieve the symptoms of patients for whom surgery is not an option.

CONDITIONS

Official Title

Efficacy of Therapy With PRP Injections Versus HA in Patients With Advanced Grade of GONArthrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • MRI confirmed grade III or IV unilateral gonarthrosis
  • Knee pain of 3 or higher on the visual analogue scale
  • Body mass index (BMI) less than 35
  • Able to give informed consent before joining the study
  • Covered by a social security or health insurance plan
Not Eligible

You will not qualify if you...

  • Use of non-steroidal anti-inflammatory drugs or corticosteroids in the 7 days before joining
  • Hyaluronic acid injection in the knee within 2 months before joining
  • Platelet Rich Plasma injection in the knee within 1 year before joining
  • Corticosteroid injection in the knee within 5 months before joining
  • Current anticoagulant treatment that cannot be stopped during the study
  • Cancer diagnosis within the past 3 years
  • Pregnant, in labor, or breastfeeding women
  • Under legal protection such as guardianship or curatorship
  • Any other condition that could interfere with study evaluation as judged by the investigator

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse

Toulon, Var, France, 83100

Actively Recruiting

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Research Team

S

Sophie Lafond

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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