Knee Osteoarthritis
Conditions
Keywords
Pain, Functional impact, Platelet Rich Plasma, hyaluronic acid, Intra-articular injection, Advanced grade
Brief 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.
Detailed description
In the PAGONA project, the investigators intend to use validated tools (WOMAC questionnaire, EVA scale, EQ-5D-5L quality of life questionnaire) to compare the effect of intra-articular injections of PRP with those of HA on the functional impact of the disease in patients with symptomatic knee osteoarthritis of moderate to severe stages (III-IV), by following these patients for 12 months after their last injection. The investigators plan to conduct a randomized, open-label study at the "Unité de Médecine et de Traumatologie du Sport" (UMTS) at Hôpital Sainte Musse in Toulon, where gonarthrosis treatment using intra-articular injections of PRP and HA is standard practice.
Interventions
PROCEDUREintra-articular injection of HA
3 injections at 7-day intervals
PROCEDUREintra-articular injection of PRP
3 injections at 15-day intervals
Sponsors
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Fondation Apicil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years ; 2. MRI confirmed grade III or IV unilateral gonarthrosis ; 3. Pain ≥ 3/10 on the visual analogue scale (VAS); 4. Patient with a BMI \< 35 5. Patient capable of giving consent prior to participation in the study; 6. Affiliated or entitled under a social security scheme.
Exclusion criteria
1. Non-steroidal anti-inflammatory drugs\* or corticosteroids\*\* taken in the 7 days prior to inclusion; 2. Local injection of hyaluronic acid in the 2 months prior to inclusion; 3. Local injection of PRP within 1 year prior to inclusion; 4. Local injection of corticosteroids within 5 months prior to inclusion; 5. Current anticoagulant treatment that cannot be stopped during the hyaluronic acid or PRP injection protocol period; 6. Patient diagnosed with any type of cancer in the last 3 years; 7. Pregnant women, women in labour or breast-feeding women; 8. Patients under judicial protection (guardianship, curatorship, etc.) or safeguard of justice; 9. Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives. * Acetylsalicylic acid is allowed when it is prescribed as an antiplatelet agent at doses lower than or equal to 160 mg per day. It has, indeed, no anti-inflammatory effect at these doses. * Corticosteroids can be administered when they have a local action different from the one applied to the treated knee (cutaneous, instiled or inhaled routes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional impact | 3 months after the last intra-articular injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional impact | up to 12 months | 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 | up to 12 months | 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 | up to 12 months | 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 | up to 12 months | 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. |
| Adverse events | up to 12 months | Number and description of adverse events related to HA or PRP injections assessed at 3 months, 6 months and 12 months after the last injection. |
Countries
France
Contacts
CONTACTSophie Lafond
STUDY_DIRECTORJean-Jacques Raymond, MD
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Outcome results
None listed