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Intraosseous PRP for Knee Osteoarthritis: Pilot Study

U

Unidad de Cirugía Artroscópica

Status and phase

Completed
Phase 2

Conditions

Knee Osteoarthritis

Treatments

Biological: Platelet Rich Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT03160781
UCA-01-EC/13/ART

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

40 to 77 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Platelet Rich Plasma
Experimental group
Description:
Combination of Intraarticular and Intraosseous Administraion of Platelet Rich Plasma
Treatment:
Biological: Platelet Rich Plasma

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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