Efficacy of Therapy With PRP Injections Versus HA in Patients With Advanced Grade of GONArthrosis
NCT ID: NCT07016672
Last Updated: 2025-11-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-18
Study Completion Date
2027-10-31
Brief Summary
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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.
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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Detailed Description
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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.
Conditions
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Knee Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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HA Injections
Group 1: HA injections (3 injections at 7-day intervals)
Group Type
ACTIVE_COMPARATOR
intra-articular injection of HA
Intervention Type
PROCEDURE
3 injections at 7-day intervals
PRP Injections
Group 2: PRP injections (3 injections at 15-day intervals)
Group Type
EXPERIMENTAL
intra-articular injection of PRP
Intervention Type
PROCEDURE
3 injections at 15-day intervals
Interventions
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intra-articular injection of HA
3 injections at 7-day intervals
Intervention Type
PROCEDURE
intra-articular injection of PRP
3 injections at 15-day intervals
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 18 years ;
2. Advanced grade 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.
2. Advanced grade 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 2 years prior to inclusion;
4. Local injection of corticosteroids within 5 months prior to inclusion;
5. Current anticoagulant treatment that cannot be stopped for the duration of the study;
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.
1\. Unilateral grade III or IV gonarthrosis not confirmed on MRI.
2. Local injection of hyaluronic acid in the 2 months prior to inclusion;
3. Local injection of PRP within 2 years prior to inclusion;
4. Local injection of corticosteroids within 5 months prior to inclusion;
5. Current anticoagulant treatment that cannot be stopped for the duration of the study;
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.
1\. Unilateral grade III or IV gonarthrosis not confirmed on MRI.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondation Apicil
OTHER
Sponsor Role
collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jean-Jacques Raymond, MD
Role: STUDY_DIRECTOR
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Locations
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Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse
Toulon, Var, France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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Jean-Jacques Raymond, MD
Role: primary
References
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Buendia-Lopez D, Medina-Quiros M, Fernandez-Villacanas Marin MA. Clinical and radiographic comparison of a single LP-PRP injection, a single hyaluronic acid injection and daily NSAID administration with a 52-week follow-up: a randomized controlled trial. J Orthop Traumatol. 2018 Aug 20;19(1):3. doi: 10.1186/s10195-018-0501-3.
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Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.
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Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.
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Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
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Raeissadat SA, Rayegani SM, Ahangar AG, Abadi PH, Mojgani P, Ahangar OG. Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Oct 10;10:1179544117733452. doi: 10.1177/1179544117733452. eCollection 2017.
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Related Links
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https://www.has-sante.fr/upload/docs/application/pdf/2022-08/fiche_aps_arthroses_vf.pdf
Related Info
https://theses.hal.science/tel-04008823
Moustafa Naja. Stratégies de prise en charge de l'arthrose de genou : innovation et évaluation médico-économique. Médecine humaine et pathologie. Université de Strasbourg, 2022. Français. ⟨NNT : 2022STRAJ031⟩. ⟨tel-04008823⟩
https://www.arthrolink.com/fr/dossiers-arthrose/tous-les-dossiers/arthrose-qualite-de-vie
Related Info
https://doi.org/10.1097/01.jaa.0000979536.73946.98
Clark, Gregory P. DMSc, MPAS, PA-C. Treatment options for symptomatic knee osteoarthritis in adults. JAAPA 36(11):p 1-6, November 2023.
Other Identifiers
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2024-A00370-47
Identifier Type: OTHER
Identifier Source: secondary_id
2024-CHITS-001
Identifier Type: -
Identifier Source: org_study_id
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