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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03160781
Enrollment
19
Registered
2017-05-19
Start date
2014-01-28
Completion date
2015-01-10
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

BIOLOGICALPlatelet Rich Plasma

Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Sponsors

Unidad de Cirugía Artroscópica
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 77 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain according to KOOS scale at 6 months after treatment6 monthsPain according to KOOS scale

Secondary

MeasureTime frameDescription
Symptoms according to KOOS scale at 6 months after treatment6 monthsAccording to KOOS scale
Function according to KOOS scale at 6 months after treatment6 monthsAccording to KOOS scale
Sport Activity according to KOOS scale at 6 months after treatment6 monthsAccording to KOOS scale
QoL according to KOOS scale at 6 months after treatment6 monthsAccording to KOOS scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026