Intraosseous PRP for Knee Osteoarthritis: Pilot Study

Study Overview
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Brief Summary
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The aim of this study was to assess a novel approach to treating severe knee osteoarthritis by targeting synovialmembrane, superficial articular cartilage, synovial fluid, and subchondral bone by combining intra-articular injections and intraosseous infiltrations of platelet rich plasma.This study explored a new strategy consisting of intraosseous infiltrations of platelet rich plasma into the subchondral bone in combination with the conventional intra-articular injection in order to tackle several knee joint tissues simultaneously.

Official Title
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Pilot Study to Evaluate Combination of Intraosseous With Intra-articular Infiltrations of Plasma Rich in Growth Factors (PRGF®-Endoret®) in the Treatment of Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged 40 to 77 years. Predominant internal tibiofemoral knee osteoarthritis. Joint pain above 2.5 VAS points. Radiographic severity degrees 3 and 4 according to Ahlbäck scale. Values of body mass index between 20 and 33. Possibility for observation during the follow-up period. Exclusion Criteria: Bilateral knee osteoarthritis which requires infiltration in both knees. Values of body mass index > 33. Polyarticular disease diagnosed. Severe mechanical deformity (diaphyseal varus of 4∘ and valgus of 16∘). Arthroscopy in the last year prior to treatment. Intra-articular infiltration of hyaluronic acid in the past 6 months. Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%). Blood disorders (thrombopathy, thrombocytopenia, and anemia with Hb < 9). Undergoing immunosuppressive therapy and/or warfarin. Treatment with corticosteroids during the 6 months prior to inclusion in the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma<br>Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma | Biological: Platelet Rich Plasma<br>* Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain according to KOOS scale at 6 months after treatment | Pain according to KOOS scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms according to KOOS scale at 6 months after treatment | According to KOOS scale | 6 months | 
| Function according to KOOS scale at 6 months after treatment | According to KOOS scale | 6 months | 
| Sport Activity according to KOOS scale at 6 months after treatment | According to KOOS scale | 6 months | 
| QoL according to KOOS scale at 6 months after treatment | According to KOOS scale | 6 months |