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OpenTrials
Completed

NCT Number: NCT03160781

Intraosseous PRP for Knee Osteoarthritis: Pilot Study

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich plasma

Biological

Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma

Primary outcomes

  1. Pain according to KOOS scale at 6 months after treatment

    Time frame: 6 months

    Pain according to KOOS scale

Secondary outcomes

  1. Symptoms according to KOOS scale at 6 months after treatment

    Time frame: 6 months

    According to KOOS scale

  2. Function according to KOOS scale at 6 months after treatment

    Time frame: 6 months

    According to KOOS scale

  3. Sport Activity according to KOOS scale at 6 months after treatment

    Time frame: 6 months

    According to KOOS scale

  4. QoL according to KOOS scale at 6 months after treatment

    Time frame: 6 months

    According to KOOS scale

Sponsors and collaborators

Lead sponsor

Unidad de Cirugía Artroscópica

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 19, 2017
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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