Pain?s treatment of the Osteoarthritic Knee
Conditions
Interventions
Product Name: Platelet rich plasma
Pharmaceutical Form: Injection
INN or Proposed INN: PRP
Other descriptive name: PLATELET CONCENTRATE
Concentration unit: ml millilitre(s)
Concentration type: equal
C
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Arthritis in the knee rated I, II, or III, VAS greater than 5, between 40 and 80 years of age. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Level IV arthritis of the knee, either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months, frontal deformity greater than 10 degrees, ipsilateral pathology of the knee or ankle, range of motion or flexibility of the knee less than 90 degrees, deficit of knee extention greater than 15 degrees, anticoagulation treatment, antiplatement treatment, hepatopathy, hematological or neoplastic pathology, active infection, fibromyalgia, or chronic fatigue syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this study is to determine the clinical value of intrarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees;Secondary Objective: Effects on function and quality of life;Primary end point(s): The results will be evaluated using the Visual Analog Scale (VAS) for the principal variable;Timepoint(s) of evaluation of this end point: Evaluation will be conducted just after treatment, after three months, and after six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Knee and Osteoarthritis Outcome System (KOOS) and the EUROQOL ( European Quality of Life) for the evaluation of function and quality of life, respectively;Timepoint(s) of evaluation of this end point: Evaluation will be conducted just after treatment, after three months, and after six months. | — |
Countries
Spain
Contacts
Public ContactProyect Manager
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Outcome results
None listed