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

Primary Purpose

the Treatment of Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
platelet-rich plasma
durolane
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Treatment of Knee Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

platelet-rich plasma

durolane

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the evolution of pain

Full Information

First Posted
September 28, 2012
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01697423
Brief Title
Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
Official Title
Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 11, 2012 (Actual)
Primary Completion Date
March 30, 2016 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Treatment of Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet-rich plasma
Arm Type
Experimental
Arm Title
durolane
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
platelet-rich plasma
Intervention Type
Drug
Intervention Name(s)
durolane
Primary Outcome Measure Information:
Title
Variation of the functional score of WOMAC
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the evolution of pain
Time Frame
12month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion Intra articular knee injection of corticosteroid or completed more than 8 weeks before inclusion Intra articular knee injection of hyaluronic or completed more than 24 weeks before inclusion NSAI treatment completed more than 2 weeks before inclusion 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
marie laure LOUIS
Organizational Affiliation
AP HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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