Intraosseous PRP for Knee Osteoarthritis: Pilot Study

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160781
• Other study ID #: UCA-01-EC/13/ART
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2017
• Last updated: May 18, 2017
• Start date: January 28, 2014
• Est. completion date: January 10, 2015

Study information

• Verified date: May 2017
• Source: Unidad de Cirugía Artroscópica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 10, 2015
• Est. primary completion date: January 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet Rich Plasma
Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Unidad de Cirugía Artroscópica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain according to KOOS scale at 6 months after treatment	Pain according to KOOS scale	6 months
Secondary	Symptoms according to KOOS scale at 6 months after treatment	According to KOOS scale	6 months
Secondary	Function according to KOOS scale at 6 months after treatment	According to KOOS scale	6 months
Secondary	Sport Activity according to KOOS scale at 6 months after treatment	According to KOOS scale	6 months
Secondary	QoL according to KOOS scale at 6 months after treatment	According to KOOS scale	6 months