Trial | NCT03160781  Report issue

Title

Intraosseous PRP for Knee Osteoarthritis: Pilot Study
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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
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.
Study Started
Jan 28
2014
Primary Completion
Jan 10
2015
Study Completion
Jan 10
2015
Last Update
May 19
2017

Biological Platelet Rich Plasma

Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Platelet Rich Plasma Experimental

Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma

Criteria 

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.
No Results Posted