Clinical trial NCT04807270: PRP Effectiveness in Knee Osteoarthritis
Official title: Efficacy of Two Different Platelet Rich Plasma Methods in Patients With Knee Osteoarthritis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
platelet rich plasma
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to determine the effects of intra-articular Platelet Rich Plasma (PRP) prepared with two different techniques on pain intensity, functional status, quality of life, functional balance and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed description: Osteoarthritis (OA) is the most common form of chronic joint disease. Platelet Rich Plasma (PRP) is an injection therapy used to treat chronic painful musculoskeletal conditions, including knee OA. In this prospective, randomized controlled, single blind, interventional study, a total of 75 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers.The patients to be included in the study will be randomized into three groups and the first group will be given platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT, the second group will be given PRP prepared with T-LAB PRP INJECTION SYRINGA, and the third group will be given saline injection. Home exercise program for knee osteoarthritis will be given to all three groups and the exercise program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments, not to make changes in their activities of daily living. Participants are going to evaluate before injection, and at the 1-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time, change in femoral cartilage thickness measurement by ultrasound and the change in the patient's daily activities with the numerical global patient assessment scale.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic symptomatic knee pain between the ages of 30-75 years
* Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
* Functional ambulation scale stage 4-5

Exclusion Criteria:

* Intra-articular knee injection within the last six months
* History of severe trauma to the knee within the past six months
* Concomitant severe meniscus or ligament injury, surgery applied to the knee area
* Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
* Having a bleeding disorder and / or using warfarin
* Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
* Presence of cardiac or systemic disease that may affect exercise
* The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
* Body Mass Index ≥35 kg / m²

Primary outcomes:
measure: Change from baseline activity pain score at 1-months and 6-months
timeFrame: Baseline, 1-month, 6-month
Secondary outcomes:
measure: Change from baseline rest pain score at 1-months and 6-months
timeFrame: Baseline, 1-month, 6-month
measure: Change from baseline night pain score at 1-months and 6-months
timeFrame: Baseline, 1-month, 6-month
measure: Change from baseline pain, stiffness and physical function at 1-months and 6-months
timeFrame: Baseline, 1-month, 6-month
measure: Change from baseline functional balance at 1-months and 6-months
timeFrame: Baseline, 1-month, 6-month
measure: Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months
timeFrame: Baseline, 6-month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatıh
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Demirhan Diracoglu, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Ekin I Sen, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: