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

NCT07016672 | Recruiting

• 2 other identifiers: 2024-CHITS-0012024-A00370-47
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Pain; Functional impact; Platelet Rich Plasma; hyaluronic acid; Intra-articular injection; Advanced grade

Outcome Measures

Primary Outcomes (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.

  3 months after the last intra-articular injection

Secondary Outcomes (5)

• Functional impact

  up to 12 months

• Pain evaluation

  up to 12 months

• Failure rate

  up to 12 months

• Quality of life evaluation

  up to 12 months

• Adverse events

  up to 12 months

Study Arms (2)

HA Injections

ACTIVE COMPARATOR

Group 1: HA injections (3 injections at 7-day intervals)

Procedure: intra-articular injection of HA

PRP Injections

EXPERIMENTAL

Group 2: PRP injections (3 injections at 15-day intervals)

Procedure: intra-articular injection of PRP

Interventions

intra-articular injection of HA PROCEDURE

3 injections at 7-day intervals

HA Injections

intra-articular injection of PRP PROCEDURE

3 injections at 15-day intervals

PRP Injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current anticoagulant treatment that cannot be stopped for the duration of the study;
• 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.

Sponsors & Collaborators

• Fondation Apicil: collaborator
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

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

Toulon, Var, 83100, France

RECRUITING

Related Publications (26)

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Related Links

• Related Info
• Related Info
• 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⟩
• Related Info
• Clark, Gregory P. DMSc, MPAS, PA-C. Treatment options for symptomatic knee osteoarthritis in adults. JAAPA 36(11):p 1-6, November 2023.

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Jacques Raymond, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Central Study Contacts

Sophie Lafond

CONTACT

0483772062; sophie.lafond@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 12, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)