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

June 11, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83100
        • Recruiting
        • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
        • Contact:
          • Jean-Jacques Raymond, MD
        • Principal Investigator:
          • Jean-Jacques Raymond, MD
        • Sub-Investigator:
          • Boris Devetakov, MD
        • Sub-Investigator:
          • Maxence De Parisot De Bernecourt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HA Injections
Group 1: HA injections (3 injections at 7-day intervals)
Procedure: intra-articular injection of HA
3 injections at 7-day intervals
Experimental: PRP Injections
Group 2: PRP injections (3 injections at 15-day intervals)
Procedure: intra-articular injection of PRP
3 injections at 15-day intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after the last intra-articular injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
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).
up to 12 months
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.
up to 12 months
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.
up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Fondation Apicil

Investigators

  • Study Director: Jean-Jacques Raymond, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 5, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-CHITS-001
  • 2024-A00370-47 (Other Identifier: IdRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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