Intraarticular and intraosseus application of plasma rich in growth factors in patients with knee osteoarthritis to improve movility and pain

Role of autologous biological therapy in knee osteoarthritis. Intraosseous application of plasma rich in growth factors , improve of functional capacity and pain, compared to intraarticular application.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000623-27-ES

Enrollment

Unknown

Registered

2017-06-20

Start date

2017-09-11

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Knee osteoarthritis. MedDRA version: 20.0 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: plasma rich in growth factors Product Code: PRGF Pharmaceutical Form: Injection INN or Proposed INN: plasma rich in growth factors Current Sponsor code: PRGF Other descriptive name: AUTO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 40 and 75. Both genders. Moderate to several pain and symptoms according to the KOOS scale of more than 6 months of evolution. Grade III- IV knee osteoathritis according to radiological criteria for the classification of Kellgren and Lawrence. Patients with no response to other pharmacological treatments. Able to fulfill the schedule of visits of the trial. BMI less than 35. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

Exclusion criteria: Intraarticular infiltration with plasma rich in growth factors in the 12 months before the inclusion Intraarticular infiltration with hyaluronic acid in the 6 months before the inclusion. Angular alterations, higher than 15 degrees and unstable joint. Systemic or local infectious disease and polyarticular disease. Cancer under treatment or under follow-up. Immunosuppressive treatment or systemic autoimmune disease. Patient with hypertension or diabetes mellitus poorly controlled. Allergy to some study drugs or excipients. Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for infiltrations. Positive to sifilis, hepatitis B, hepatitis C or VIH+. Uncapable to understand or fulfill the questionnaries of the study.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To evaluate the effectiveness at 12 months measured in the KOOS scale To evaluate the effectiveness at 6 and 12 months measured in the WOMAC scale To assess radiological changes in the subchondral bone To asses the safety of the administration of plasma rich in growth factors;Primary end point(s): Score at 6 months in the KOOS scale;Timepoint(s) of evaluation of this end point: 6 months;Main Objective: The main objective is to assess the effectiveness at 6 months, defined as improvement in the functionality and pain mesaured in the KOOS scale, of the intraarticular and intraosseus application of plasma rich in growth factors versus the intraarticular application of plasma rich in growth factors plus intraosseus administration of placebo.	—

Measure

Time frame

Secondary Objective: To evaluate the effectiveness at 12 months measured in the KOOS scale To evaluate the effectiveness at 6 and 12 months measured in the WOMAC scale To assess radiological changes in the subchondral bone To asses the safety of the administration of plasma rich in growth factors;Primary end point(s): Score at 6 months in the KOOS scale;Timepoint(s) of evaluation of this end point: 6 months;Main Objective: The main objective is to assess the effectiveness at 6 months, defined as improvement in the functionality and pain mesaured in the KOOS scale, of the intraarticular and intraosseus application of plasma rich in growth factors versus the intraarticular application of plasma rich in growth factors plus intraosseus administration of placebo.

—

Secondary

Measure	Time frame
Secondary end point(s): Score at 12 months in the KOOS scale Score at 6 and 12 months in the WOMAC scale;Timepoint(s) of evaluation of this end point: 6 and 12 months	—

Countries

Spain

Contacts

Public ContactVíctor Vaquerizo

Hospital Principe de Asturias

vaquerizovictor@yahoo.es+349188781002454

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026