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Efficacy of Therapy With Intra-articular Injections of PRP Compared With Therapy With Intra-articular Injections of HA, in Patients With Grade III or IV GONArthrosis: a Prospective Randomized Open-label Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years ;

• MRI confirmed grade III or IV unilateral gonarthrosis ;

• Pain ≥ 3/10 on the visual analogue scale (VAS);

• Patient with a BMI \< 35

• Patient capable of giving consent prior to participation in the study;

• Affiliated or entitled under a social security scheme.

Locations
Other Locations
France
Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
RECRUITING
Toulon
Contact Information
Primary
Sophie Lafond
sophie.lafond@ch-toulon.fr
0483772062
Time Frame
Start Date: 2025-09-18
Estimated Completion Date: 2027-10
Participants
Target number of participants: 150
Treatments
Active_comparator: HA Injections
Group 1: HA injections (3 injections at 7-day intervals)
Experimental: PRP Injections
Group 2: PRP injections (3 injections at 15-day intervals)
Related Therapeutic Areas
Sponsors
Collaborators: Fondation Apicil
Leads: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

This content was sourced from clinicaltrials.gov

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