Intraosseous PRP for Knee Osteoarthritis: Pilot Study
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet Rich Plasma
Arm Description
Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
Outcomes
Primary Outcome Measures
Pain according to KOOS scale at 6 months after treatment
Pain according to KOOS scale
Secondary Outcome Measures
Symptoms according to KOOS scale at 6 months after treatment
According to KOOS scale
Function according to KOOS scale at 6 months after treatment
According to KOOS scale
Sport Activity according to KOOS scale at 6 months after treatment
According to KOOS scale
QoL according to KOOS scale at 6 months after treatment
According to KOOS scale
Full Information
NCT ID
NCT03160781
First Posted
May 17, 2017
Last Updated
May 18, 2017
Sponsor
Unidad de Cirugía Artroscópica
1. Study Identification
Unique Protocol Identification Number
NCT03160781
Brief Title
Intraosseous PRP for Knee Osteoarthritis: Pilot Study
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 28, 2014 (Actual)
Primary Completion Date
January 10, 2015 (Actual)
Study Completion Date
January 10, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unidad de Cirugía Artroscópica
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm Description
Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma
Primary Outcome Measure Information:
Title
Pain according to KOOS scale at 6 months after treatment
Description
Pain according to KOOS scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Symptoms according to KOOS scale at 6 months after treatment
Description
According to KOOS scale
Time Frame
6 months
Title
Function according to KOOS scale at 6 months after treatment
Description
According to KOOS scale
Time Frame
6 months
Title
Sport Activity according to KOOS scale at 6 months after treatment
Description
According to KOOS scale
Time Frame
6 months
Title
QoL according to KOOS scale at 6 months after treatment
Description
According to KOOS scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
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 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraosseous PRP for Knee Osteoarthritis: Pilot Study
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