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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03082430
• Other study ID #: GO PRP
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2018
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to monitor and follow the evolution of pain	VAS to monitor and follow the evolution of pain	prior,1 month, 3 months, 6 months
Primary	to monitor and follow the evolution of the knee function	(KOOS score)	prior,1 month, 3 months, 6 months
Primary	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.	prior,1 month, 3 months, 6 months