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.

Unidad de Cirugía Artroscópica0 sites19 target enrollmentJanuary 28, 2014

ConditionsKnee Osteoarthritis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Unidad de Cirugía Artroscópica
Enrollment: 19
Primary Endpoint: Pain according to KOOS scale at 6 months after treatment
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 28, 2014

End Date

January 10, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Unidad de Cirugía Artroscópica

Responsible Party

Sponsor

Eligibility 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
•Possibility for observation during the follow-up period.

Exclusion Criteria

•Bilateral knee osteoarthritis which requires infiltration in both knees.
•Values of body mass index \>
•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.