Skip to main content
OpenTrials
Completed

NCT Number: NCT04807270

PRP Effectiveness in Knee Osteoarthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatıh, 34034, Turkey (Türkiye)

About this study

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, double blind, interventional study, out of 154 patients who applied to the physical medicine and rehabilitation department, 96 patients who met the eligibility criteria were divided into the pure PRP group without anticoagulant (n=32), amber PRP group (n=32), and saline group (n=32). A home exercise program for knee osteoarthritis will be provided to all three groups, and the program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments and not to changes to their activities of daily living. Participants are going to be evaluated using visual analog scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a numeric rating scale for quality of life (NRS) baseline and at 1, 3, and 6-month follow-up periods, time Up and Go (TUG) test at the baseline and at 3 and 6 months after treatment, and changes in femoral cartilage thickness by ultrasound measurement at the baseline and at 6 months after treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic symptomatic knee pain between the ages of 30 and 75 years
  • Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
  • The ability to walk independently

Exclusion criteria

  • Previous treatment with an autologous blood product or stem cell preparation
  • Severe knee effusion
  • Concomitant severe meniscus or ligament injury
  • Recent cancer or other tumors
  • History of knee surgery
  • Previous diagnosis of a neuromuscular, infectious, or inflammatory disease
  • Bleeding disorders and/or use of warfarin
  • Body mass index above 40 kg/m²
  • Cardiac or systemic diseases that could affect participation in the exercise program

Treatment and study plan

Intra-articular T-LAB / Next PRP Syringe

Other

Anticoagulant-free pure PRP will be prepared using T-LAB / Next PRP Syringe. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intra-articular T-LAB / PRP KIT injection

Other

PRP containing anticoagulant will be prepared using T-LAB / PRP KIT. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intra-articular SALINE injection

Other

Similar to the PRP protocol, 4 mL of 0.9% sodium chloride will be injected intra-articularly. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Primary outcomes

  1. Change from baseline activity pain score at 1-months, 3-months and 6-months

    Time frame: Baseline, 1-month, 3-month, 6-month

    Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

Secondary outcomes

  1. Change from baseline activity pain score at 1-months, 3-months and 6-months

    Time frame: Baseline, 1-month, 3-month, 6-month

    Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome

  2. Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months

    Time frame: Baseline, 1-month, 3-month, 6-month

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed, with possible ranges of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.

  3. Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months

    Time frame: Baseline, 1-month, 3-month, 6-month

    Quality of life and global assessment evaluate using a numeric rating scale (NRS) ranging from 0 to 10. Higher scores mean a worse outcome..

  4. Change from baseline functional balance at 3-months and 6-months

    Time frame: Baseline, 3-month, 6-month

    The Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 meters at a comfortable speed to the marked place on the floor, turn around, walk backwards to the starting point, and return to the sitting position in the chair. The time taken for the person to complete the test is measured in seconds. The timing of the test is related to the function.

  5. Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months

    Time frame: Baseline, 6-month

    Distal femoral cartilage thickness will be evaluated by the same clinician. We will use the MyLab60 model ultrasonography device and a high-resolution 7-12 MHz linear probe available in our clinic. During measurement, patients will be prone with knees in full flexion and ankles in neutral. The probe will be placed axially in the suprapatellar area at the outer edge of the patella. The distal femoral cartilage will be imaged anechogenically between the hyperechogenic bony cortex and suprapatellar fat. Next, we will measure the distance between the thin hyperechoic line of the synovial cavity on the stratified face and the hyperechoic sharp line on the bony face of the cartilage. This will be recorded as the thickness of the cartilage. For each intervention knee, cartilage thickness will be determined by recording three measurements from the midpoint: lateral condyle, intercondylar area, and medial condyle.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparative Efficacy of Two Platelet-Rich Plasma Treatments For Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial

Acronym: PRP

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 19, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.