Intraosseous PRP for Knee Osteoarthritis: Pilot Study

May 18, 2017 updated by: Unidad de Cirugía Artroscópica

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet Rich Plasma
Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
Biological: Platelet Rich Plasma
Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain according to KOOS scale at 6 months after treatment
Time Frame: 6 months
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
Time Frame: 6 months
According to KOOS scale
6 months
Function according to KOOS scale at 6 months after treatment
Time Frame: 6 months
According to KOOS scale
6 months
Sport Activity according to KOOS scale at 6 months after treatment
Time Frame: 6 months
According to KOOS scale
6 months
QoL according to KOOS scale at 6 months after treatment
Time Frame: 6 months
According to KOOS scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad de Cirugía Artroscópica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2014

Primary Completion (Actual)

January 10, 2015

Study Completion (Actual)

January 10, 2015

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCA-01-EC/13/ART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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