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

NCT01697423 | Completed Phase 2 DMC

• 2 other identifiers: 2012-003565-182011-25
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

the Treatment of Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the evolution of pain

  12month

Study Arms (2)

platelet-rich plasma

EXPERIMENTAL

Drug: platelet-rich plasma

durolane

ACTIVE COMPARATOR

Drug: durolane

Interventions

platelet-rich plasma DRUG

platelet-rich plasma

durolane DRUG

durolane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. HB \> 10g/dl 7. Negative pregnancy test

You may not qualify if:

• Axial deformity of the lower limb over 5°
• Knee instability
• BMI \< 20 or \> 30
• Thrombocytopenia \< 150 G/L
• Thrombopathy
• Anaemia: HB \< 10g/dl
• Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
• Fever or recent disease
• Auto immune disease
• Inflammatory Arthritis
• Immune deficit
• Infectious disease
• Pregnancy
• Patient under guardianship.
• Participation in another investigational trial within this trial

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• BERNARD BELAIGUES

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

• marie laure LOUIS

  AP HM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: December 11, 2012
• Primary Completion: March 30, 2016
• Study Completion: November 29, 2017
• Last Updated: April 21, 2023

Record last verified: 2017-07

Locations

FR (1)