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.
1 other identifier
interventional
19
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 knee-osteoarthritis
Started Jan 2014
Shorter than P25 for phase_2 knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2015
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedMay 19, 2017
May 1, 2017
12 months
May 17, 2017
May 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain according to KOOS scale at 6 months after treatment
Pain according to KOOS scale
6 months
Secondary Outcomes (4)
Symptoms according to KOOS scale at 6 months after treatment
6 months
Function according to KOOS scale at 6 months after treatment
6 months
Sport Activity according to KOOS scale at 6 months after treatment
6 months
QoL according to KOOS scale at 6 months after treatment
6 months
Study Arms (1)
Platelet Rich Plasma
EXPERIMENTALCombination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
Interventions
Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 19, 2017
Study Start
January 28, 2014
Primary Completion
January 10, 2015
Study Completion
January 10, 2015
Last Updated
May 19, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share