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Knee OsteoarthritisPAGONANCT07016672

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

A study testing intra-articular injection of HA and intra-articular injection of PRP in people with Knee Osteoarthritis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
intra-articular injection of HA and intra-articular injection of PRP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
18 Sep 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse

    Toulon, Var, 83100

    Jean-Jacques Raymond, MD

    Jean-Jacques Raymond, MD

    Recruiting

Other trials in France

About this study

Official 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

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.

Read more

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.

Read the 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.

Being tested
intra-articular injection of HA, intra-articular injection of PRP
Keywords
Pain, Functional impact, Platelet Rich Plasma, hyaluronic acid, Intra-articular injection, Advanced grade
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intra-articular injection of HAProcedure or surgery

    3 injections at 7-day intervals

  • intra-articular injection of PRPProcedure or surgery

    3 injections at 15-day intervals

Study groups in NCT07016672
Study groupRoleWhat they receive
HA InjectionsActive comparatorGroup 1: HA injections (3 injections at 7-day intervals)
Receives: Procedure: intra-articular injection of HA
PRP InjectionsExperimentalGroup 2: PRP injections (3 injections at 15-day intervals)
Receives: Procedure: intra-articular injection of PRP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after the last intra-articular injection

Secondary outcomes (5)
  1. 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.

    Measured: up to 12 months

  2. 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).

    Measured: up to 12 months

  3. 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.

    Measured: up to 12 months

  4. 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.

    Measured: up to 12 months

  5. Adverse events

    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.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2025
  2. Study start18 Sep 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07016672
Sponsor's protocol ID
2024-CHITS-001
Other IDs
2024-A00370-47
Acronym
PAGONA
Status last verified
Jul 2026
First submitted
27 May 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vincent P. Acide hyaluronique intra articulaire dans la gonarthrose: une etude long-terme, ouverte, de Phase IV, avec analyse detaillee par stade de Kellgren-Lawrence. Curr Ther Res Clin Exp. 2020 May 27;92:100588. doi: 10.1016/j.curtheres.2020.100588. eCollection 2020.

    PubMed 32714470
  • Papalia R, Torre G, Zampogna B, Vorini F, Grasso A, Denaro V. Sport activity as risk factor for early knee osteoarthritis. J Biol Regul Homeost Agents. 2019 Mar-Apr;33(2 Suppl. 1):29-37. XIX Congresso Nazionale S.I.C.O.O.P. Societa' Italiana Chirurghi Ortopedici Dell'ospedalita' Privata Accreditata.

    PubMed 31169000
  • Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.

    PubMed 32931933
  • Nuesch E, Dieppe P, Reichenbach S, Williams S, Iff S, Juni P. All cause and disease specific mortality in patients with knee or hip osteoarthritis: population based cohort study. BMJ. 2011 Mar 8;342:d1165. doi: 10.1136/bmj.d1165.

    PubMed 21385807
  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

    PubMed 3741515
  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PubMed 3068365
  • Zheng H, Chen C. Body mass index and risk of knee osteoarthritis: systematic review and meta-analysis of prospective studies. BMJ Open. 2015 Dec 11;5(12):e007568. doi: 10.1136/bmjopen-2014-007568.

    PubMed 26656979
  • Eymard F, Ornetti P, Maillet J, Noel E, Adam P, Legre-Boyer V, Boyer T, Allali F, Gremeaux V, Kaux JF, Louati K, Lamontagne M, Michel F, Richette P, Bard H; GRIP (Groupe de Recherche sur les Injections de PRP, PRP Injection Research Group). Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3195-3210. doi: 10.1007/s00167-020-06102-5. Epub 2020 Jun 24.

    PubMed 32583023
  • Alcerro JC, Lavernia CJ. Stem Cells and Platelet-rich Plasma for Knee Osteoarthritis: Prevalence and Cost in South Florida. J Am Acad Orthop Surg. 2019 Oct 15;27(20):779-783. doi: 10.5435/JAAOS-D-18-00343.

    PubMed 30499895
  • McElheny K, Toresdahl B, Ling D, Mages K, Asif I. Comparative Effectiveness of Alternative Dosing Regimens of Hyaluronic Acid Injections for Knee Osteoarthritis: A Systematic Review. Sports Health. 2019 Sep/Oct;11(5):461-466. doi: 10.1177/1941738119861545. Epub 2019 Jul 24.

    PubMed 31340715
  • Chu CR, Rodeo S, Bhutani N, Goodrich LR, Huard J, Irrgang J, LaPrade RF, Lattermann C, Lu Y, Mandelbaum B, Mao J, McIntyre L, Mishra A, Muschler GF, Piuzzi NS, Potter H, Spindler K, Tokish JM, Tuan R, Zaslav K, Maloney W. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019 Jan 15;27(2):e50-e63. doi: 10.5435/JAAOS-D-18-00305.

    PubMed 30300216
  • Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.

    PubMed 26233594
  • Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.

    PubMed 30611335
  • Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.

    PubMed 23299850
  • Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

    PubMed 26831629

Questions about this trial

What is this clinical trial studying?

A study testing intra-articular injection of HA and intra-articular injection of PRP in people with Knee Osteoarthritis, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Lafond (0483772062 ext. +33, sophie.lafond@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional impact (time frame: 3 months after the last intra-articular injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07016672, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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