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GO PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

autologous PRP.

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women 20 to 80 years
Gonarthrosis diagnostic objectified by the criteria of the American College of Rheumatology
Joint pain for more than 6 months
Answer "moderate" to the question about pain walking on flat ground
Answer "moderate" to the question about trouble walking on flat ground
Osteoarthritis stage 2 or 3 on the scale of Kellgren Lawrence (objectified radiography) within 6 months previous inclusion
Axial deformation of less than or equal to 5 ° lower limbs
Informed consent signed by the patient
HB> 10g / dl
Beta-HCG negative at baseline
Ability to perform the procedures in the follow-up (50 not walk on a flat surface and up / down stairs).
Being affiliated to a system of health insurance

Exclusion criteria:

Axial deformation > 5 °
Ligamentous instability
Significant injuries or target knee or knee surgery contralateral side in 12 months previous the inclusion visit
Ligament reconstruction in the 12 months précédants the inclusion visit
Need a cane or assistance to move
BMI> 35
Thrombocytopenia <150 G / L
Thrombocytosis> 450 G / L
Known thrombopathy
Anemia HB <10g / dl
Active infections to HIV 1 and 2, Agp24, HCV Ab, Ag and HbS AcHbc, Ac HTLV I and II, TPHA
Chronic treatment with corticosteroids per os or older than 2 weeks
Injection intra-articular corticosteroid of less than 2 months
Intra-articular injection of hyaluronic acid of less than 6 months
NSAIDs or antiplatelet agent of less than 15 days
Inability to stop NSAIDs (including aspirin) 15 days before the injection and the week following the injection
Fever or recent illness
Autoimmune diseases
Inflammatory arthritis
Immune deficiency
Infectious diseases
Pregnant women
Adults legally protected (under guardianship and trusteeship)
People simultaneously participating in other biomedical research16. Inability

Sites / Locations

Hopital Saint Joseph

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

knee osteoarthritis patients.

Arm Description

therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation.

Outcomes

Primary Outcome Measures

to monitor and follow the evolution of pain

VAS to monitor and follow the evolution of pain

to monitor and follow the evolution of the knee function

(KOOS score)

Evaluation of MRI

Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.

Secondary Outcome Measures

Full Information

NCT ID

NCT03082430

First Posted

March 6, 2017

Last Updated

May 3, 2018

Sponsor

Hospital St. Joseph, Marseille, France

1. Study Identification

Unique Protocol Identification Number

NCT03082430

Brief Title

GO PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

Official Title

Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation

Detailed Description

The main objective is to get a 50% proportion of responders defined by answers "absent" or "light" in the KOOS questionnaire on questions about pain and difficulty walking on flat ground. Secondary objectives include the safety validation of the use of PRP (prepared standardized manner by means of a given medical device) as second-line standard of care for osteoarthritis by the introduction of a systematic monitoring; and the feasibility of the health care system dedicated to the treatment of knee osteoarthritis by autologous PRP. Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS) and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.

6. Conditions and Keywords

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

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

descriptive study

Masking

None (Open Label)

Masking Description

study for knee osteoarthritis patients treated in the center

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

knee osteoarthritis patients.

Arm Type

Other

Arm Description

Intervention Type

Biological

Intervention Name(s)

autologous PRP.

Intervention Description

one autologous PRP patient in this study and monitor and follow the evolution of pain and the knee function

Primary Outcome Measure Information:

Title

to monitor and follow the evolution of pain

Description

VAS to monitor and follow the evolution of pain

Time Frame

prior,1 month, 3 months, 6 months

Title

to monitor and follow the evolution of the knee function

Description

(KOOS score)

Time Frame

prior,1 month, 3 months, 6 months

Title

Evaluation of MRI

Description

Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.

Time Frame

prior,1 month, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women 20 to 80 years Gonarthrosis diagnostic objectified by the criteria of the American College of Rheumatology Joint pain for more than 6 months Answer "moderate" to the question about pain walking on flat ground Answer "moderate" to the question about trouble walking on flat ground Osteoarthritis stage 2 or 3 on the scale of Kellgren Lawrence (objectified radiography) within 6 months previous inclusion Axial deformation of less than or equal to 5 ° lower limbs Informed consent signed by the patient HB> 10g / dl Beta-HCG negative at baseline Ability to perform the procedures in the follow-up (50 not walk on a flat surface and up / down stairs). Being affiliated to a system of health insurance Exclusion criteria: Axial deformation > 5 ° Ligamentous instability Significant injuries or target knee or knee surgery contralateral side in 12 months previous the inclusion visit Ligament reconstruction in the 12 months précédants the inclusion visit Need a cane or assistance to move BMI> 35 Thrombocytopenia <150 G / L Thrombocytosis> 450 G / L Known thrombopathy Anemia HB <10g / dl Active infections to HIV 1 and 2, Agp24, HCV Ab, Ag and HbS AcHbc, Ac HTLV I and II, TPHA Chronic treatment with corticosteroids per os or older than 2 weeks Injection intra-articular corticosteroid of less than 2 months Intra-articular injection of hyaluronic acid of less than 6 months NSAIDs or antiplatelet agent of less than 15 days Inability to stop NSAIDs (including aspirin) 15 days before the injection and the week following the injection Fever or recent illness Autoimmune diseases Inflammatory arthritis Immune deficiency Infectious diseases Pregnant women Adults legally protected (under guardianship and trusteeship) People simultaneously participating in other biomedical research16. Inability

Facility Information:

Facility Name

Hopital Saint Joseph

City

Marseille

ZIP/Postal Code

13008

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

GO PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

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