Intra-articular Infiltration of Platelet-Rich Fibrin Vs Corticosteroid in Mild to Moderate Knee Osteoarthritis
90 patients around the world
Available in Brazil
The objective of this work is to compare the efficacy of intra-articular injection of PRF
versus intra-articular application of corticosteroid in the treatment of patients with
mild to moderate knee osteoarthritis This study will be a prospective, randomized,
double-blind, comparative clinical trial with a 1:1 allocation ratio following the
CONSORT (Consolidated Standards of Reporting Trials) guidelines. Patients with knee
osteoarthritis will be screened at the Knee Outpatient Clinic of the Department of
Orthopedics and Traumatology of EPM-UNIFESP.
The Intervention Group consists of intra-articular application of PRF in the knee, while
the Control Group consists of intra-articular application of corticosteroids in the knee.
For patients in both groups (PRF or corticosteroid), 40ml of venous blood will be
collected for the preparation of PRF, and the infiltration will be performed or not,
according to random allocation. For patients in the corticosteroid group, the blood
sample will be discarded.
The Intervention Group consists of intra-articular application of PRF in the knee. The
applications will be performed by the same physician. Patients will be blinded to ensure
they do not know which group each individual belongs to. Three applications of PRF will
be carried out with intervals of 14 to 28 days between them.
A total of 10ml of PRF will be applied intra-articularly, on an outpatient basis, with
patients being instructed to follow the same physical therapy and rehabilitation
protocol. There will be no restrictions on weight-bearing or range of motion in the knee
during the application. As a rescue medication for pain, if VAS > 3, patients may use
Paracetamol 750mg every 6 hours per day and/or Dipyrone up to 1g every 6 hours per day.
If they experience VAS > 7, they may use Tramadol 100mg every 6 hours, with all
medications being monitored.
The procedures will be performed by the same doctor. The patients will be blinded so that
they do not know to which group each individual belongs. In this group, 40ml of
peripheral blood will also be collected and placed for centrifugation. During the
preparation for the application, a nurse (who will not participate in the study) will
have a list of the randomization and will prepare the material in an opaque syringe
(blinding both the applicator and the patient).
In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be
administered in the first application and 3ml of saline in the second and third
applications, with intervals of 14 to 28 days between the applications. The applications
will be performed on an outpatient basis, with patients being advised to follow the same
protocol for physiotherapy and rehabilitation. There will be no restrictions on load or
range of motion in the knee being treated. As rescue medication for pain, if the Visual
Analog Scale (VAS) score is greater than 3, patients may use Paracetamol 750mg every 6
hours per day and/or Dipyrone up to 1g every 6 hours per day. If they have a VAS score
greater than 7, they may use Tramadol 100mg every 6 hours, with all medications being
monitored.
The assessments will include the Visual Analog Scale for Pain and the WOMAC
questionnaire. The primary outcome will be the WOMAC (Pain subscale). The average time to
complete these questionnaires is 10 minutes. All outcomes will be assessed at the time of
inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18
months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to
investigate possible complications. Additionally, evaluations of other secondary outcomes
such as physiotherapy participation, amount of analgesic use, and knee range of motion
will be conducted.
The questionnaires will be sent and answered by patients electronically, and the analyses
will be carried out by a statistician. Patients and statisticians performing the
assessments and analyses will be blinded to each task so that they do not know to which
group each individual belongs.
A clinical failure will be considered if a patient's pain is greater than or equal to the
pain they experienced before the interventions, occurring more than 50% of the days in
the last month or assessment period (the period between evaluations). These failures will
be reported as efficacy over 6 months, 1 year, and 2 years. Based on these results, the
patient may undergo another treatment (which could be the same treatment they previously
received or not).
Federal University of São Paulo
1Research sites
90Patients around the world
This study is for people with
Osteoarthritis
Gonarthrosis
Requirements for the patient
From 50 Years
All Gender
Medical requirements
Age 50 years or older.
Who have not improved with non-surgical treatment for at least 3 months, ability to sign a consent form, average visual analog scale > 40/100 (over at least 7 days in the previous month).
Mild or moderate knee osteoarthritis diagnosed by radiographic imaging grade 2 or 3 according to the Kellgren-Lawrence classification.
Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.
Angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia > 4º varus or > 16º valgus).