PRP Effectiveness in Knee Osteoarthritis

Istanbul University

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: Intra-articular T-LAB / PRP INJECTION SYRINGE injection; Other: Intra-articular T-LAB / PRP KIT injection; Other: Intra-articular SALINE injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04807270

Istanbul Universty PRP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

T-LAB / PRP KIT

Active Comparator group

Description:

In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT injection in 3 sessions will be applied.

Treatment:

Other: Intra-articular T-LAB / PRP KIT injection

T-LAB / PRP INJECTION SYRINGE

Active Comparator group

Description:

In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied.

Treatment:

Other: Intra-articular T-LAB / PRP INJECTION SYRINGE injection

SALINE

Active Comparator group

Description:

In the first group, Platelet-rich plasma (PRP) prepared with SALINE injection in 3 sessions will be applied.

Treatment:

Other: Intra-articular SALINE injection