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NCT Number: NCT07016672

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulon, Var, 83100, France

Location status: Recruiting

Location contact

Boris Devetakov, MD

SUB_INVESTIGATOR

Jean-Jacques Raymond, MD

CONTACT

Jean-Jacques Raymond, MD

PRINCIPAL_INVESTIGATOR

Maxence De Parisot De Bernecourt, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Current anticoagulant treatment that cannot be stopped during the hyaluronic acid or PRP injection protocol period;
  • Patient diagnosed with any type of cancer in the last 3 years;
  • Pregnant women, women in labour or breast-feeding women;
  • Patients under judicial protection (guardianship, curatorship, etc.) or safeguard of justice;
  • 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).

Treatment and study plan

intra-articular injection of HA

Procedure

3 injections at 7-day intervals

intra-articular injection of PRP

Procedure

3 injections at 15-day intervals

Primary outcomes

  1. Functional impact

    Time frame: 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 outcomes

  1. Functional impact

    Time frame: 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.

  2. Pain evaluation

    Time frame: 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).

  3. Failure rate

    Time frame: 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.

  4. Quality of life evaluation

    Time frame: 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.

  5. Adverse events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Lafond

CONTACT

[email protected]

0483772062 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Fondation Apicil

Registry information

Official study title

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

Acronym: PAGONA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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