Intraosseous PRP for Knee Osteoarthritis: Pilot Study

NCT ID: NCT03160781

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-28

Study Completion Date

2015-01-10

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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet Rich Plasma

Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Interventions

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Platelet Rich Plasma

Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidad de Cirugía Artroscópica

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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UCA-01-EC/13/ART

Identifier Type: -

Identifier Source: org_study_id

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