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.
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
Non-steroidal anti-inflammatory drugs* or corticosteroids** taken in the 7 days prior to inclusion;
Local injection of hyaluronic acid in the 2 months prior to inclusion;
Local injection of PRP within 1 year prior to inclusion;
Local injection of corticosteroids within 5 months prior to inclusion;
Parallel
intra-articular injection of HA
Procedure/Surgery3 injections at 7-day intervals
intra-articular injection of PRP
Procedure/Surgery3 injections at 15-day intervals
Functional impact
The functional impact of the gonarthrosis will be assessed by the global WOMAC score, before injections and 3 months after the last injection, compared with the same score before treatment in each treatment group. The questionnaire consists of 24 questions divided into 3 categories: pain, physical function and stiffness. Each category offers a possible score range of 0 to 20 for pain, 0 to 68 for physical function, and 0 to 8 for stiffness. The sum of the scores for the three categories gives the total WOMAC score. The higher the score, the greater the functional impact of the gonarthrosis.
Functional impact
The functional impact of the gonarthrosis will be assessed by the global WOMAC score, before injections and at 6 and 12 months after the last injection, compared with the same score before treatment in each treatment group. Evaluation of the overall WOMAC score beyond 3 months, and in each component of the WOMAC score (pain, stiffness and functional discomfort). The questionnaire consists of 24 questions divided into 3 categories: pain, physical function and stiffness. Each category offers a possible score range of 0 to 20 for pain, 0 to 68 for physical function, and 0 to 8 for stiffness. The sum of the scores for the three categories gives the total WOMAC score. The higher the score, the greater the functional impact of the gonarthrosis.
Pain evaluation
The patient's pain will be assessed before the 1st injection, at 3 months, 6 months and 12 months after the last injection using a Digital Visual Scale. The Visual Digital Pain Scale is a self-assessment pain intensity scale. It is used to quantify the pain felt by patients and to monitor its evolution. It is scored using 11 numbers, ranging from 0 ("No pain") to 10 ("Maximum imaginable pain"). Patients are asked to choose the number corresponding to the intensity of their pain. This scale gives a score from 0 to 10 (0 to 10 cm).
Failure rate
Therapeutic failure, defined as recourse to surgery (knee prosthesis) and/or recourse to additional injections of PRP or HA to relieve the patient and/or the occurrence of an intra-articular infection, assessed up to 12 months after the last injection.
Quality of life evaluation
EQ-5D-5L quality of life questionnaire scores assessed before the 1st injection, at 3 months, 6 months and 12 months after the last injection. EQ-5D-5L scores range from -0.59 to 1, where 1 is the best possible health status.
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead sponsor
Fondation Apicil
Collaborator
