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

NCT03082430 | Unknown

• 1 other identifier: GO PRP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• to monitor and follow the evolution of pain

  VAS to monitor and follow the evolution of pain

  prior,1 month, 3 months, 6 months

• to monitor and follow the evolution of the knee function

  (KOOS score)

  prior,1 month, 3 months, 6 months

• 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

Study Arms (1)

knee osteoarthritis patients.

OTHER

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.

Biological: autologous PRP.

Interventions

autologous PRP. BIOLOGICAL

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

knee osteoarthritis patients.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Axial deformation \> 5 °
• Ligamentous instability
• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Joseph

Marseille, 13008, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: study for knee osteoarthritis patients treated in the center
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: descriptive study

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 17, 2017
• Study Start: January 19, 2017
• Primary Completion: February 28, 2018
• Study Completion: September 30, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)