Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis

the Treatment of Knee Osteoarthritis Clinical Trial

Official title:

Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697423
• Other study ID #: 2012-003565-18
• Secondary ID: 2011-25
• Status: Completed
• Phase: Phase 2
• Start date: December 11, 2012
• Est. completion date: November 29, 2017

Study information

• Verified date: July 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The aim of the treatment of symptomatic osteoarthritis consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients.

The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular injections are proposed.

Intra articular injections of hyaluronic acid are recommended by the American College of Rheumatology and the European League against Rheumatism for the treatment of knee osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the duration of clinical improvement which does not exceed 6 months.

The articular cartilage has a limited capacity for self-repair due to the low mitotic activity of chondrocytes and its avascularity.

Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and the cytokines, liberated by platelet degranulation. The influence of these growth factors in the cartilage repair is being widely investigated in vivo and in vitro. These factors could stimulate the chondral reparation via a neovascularization, a collagen synthesis and an activation of the chondrocytes.

The hypothesis is that the intra articular injection of PRP, with its capacity to enhance articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the treatment of knee osteoarthritis resisting the oral drugs.

Material and methods: We intend to conduct a comparative, monocentric prospective randomized, double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 29, 2017
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Males and females between 20 to 75 years of age 2. Symptomatic knee arthritis 3. Axial deformity of the lower limb equal or lower than 5° 4. BMI between 20 to 30 5. Written informed consent, signed by patient or legal representative (if patient unable to sign).

6. HB > 10g/dl 7. Negative pregnancy test

Exclusion Criteria:

1. Axial deformity of the lower limb over 5°

2. Knee instability

3. BMI < 20 or > 30

4. Thrombocytopenia < 150 G/L

5. Thrombopathy

6. Anaemia: HB < 10g/dl

7. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA

8. Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion

9. Intra articular knee injection of corticosteroid or completed more than 8 weeks before inclusion

10. Intra articular knee injection of hyaluronic or completed more than 24 weeks before inclusion

11. NSAI treatment completed more than 2 weeks before inclusion

12. Fever or recent disease

13. Auto immune disease

14. Inflammatory Arthritis

15. Immune deficit

16. Infectious disease

17. Pregnancy

18. Patient under guardianship.

19. Participation in another investigational trial within this trial

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• the Treatment of Knee Osteoarthritis

Intervention

Drug:
• platelet-rich plasma

• durolane

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the functional score of WOMAC	evaluate the non inferiority between platelet-rich plasma (PRP) and hyaluronic acid. onthé evolution of the knee function, by assessing the difference with a functional score (WOMAC), before and 3 months after treatment.	12 months
Secondary	the evolution of pain		12month