Intraosseous PRP for Knee Osteoarthritis: Pilot Study

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Platelet Rich Plasma

• Registration Number: NCT03160781
• Lead Sponsor: Unidad de Cirugía Artroscópica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-28
• Primary Completion: 2015-01-10
• Study Completion: 2015-01-10
• Status Verified: 2017-05
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Last Update Submitted: 2017-05-18
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Platelet Rich Plasma	Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma

Primary Outcome Measures

Name	Time	Method
Pain according to KOOS scale at 6 months after treatment	6 months	Pain according to KOOS scale

Secondary Outcome Measures

Name	Time	Method
Symptoms according to KOOS scale at 6 months after treatment	6 months	According to KOOS scale
Function according to KOOS scale at 6 months after treatment	6 months	According to KOOS scale
Sport Activity according to KOOS scale at 6 months after treatment	6 months	According to KOOS scale
QoL according to KOOS scale at 6 months after treatment	6 months	According to KOOS scale