PRP Effectiveness in Knee Osteoarthritis (PRP)

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Intra-articular T-LAB / Next PRP Syringe; Other: Intra-articular T-LAB / PRP KIT injection; Other: Intra-articular SALINE injection

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, 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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Fatıh
    • Istanbul, Fatıh, Turkey (Türkiye), 34034
      • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T-LAB / NEXT PRP SYRINGE; In the first group (PRP1 group; non-anticoagulant pure PRP), prepared with Next PRP Syringe in 3 sessions will be applied.	Other: Intra-articular T-LAB / Next PRP Syringe; 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.
Active Comparator: T-LAB / PRP KIT; In the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied.	Other: Intra-articular T-LAB / PRP KIT injection; 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.
Sham Comparator: SALINE; In the third group (saline group), prepared with SALINE in 3 sessions will be applied.	Other: Intra-articular SALINE injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline activity pain score at 1-months, 3-months and 6-months	Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month, 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline activity pain score at 1-months, 3-months and 6-months	Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month, 6-month
Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months	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.	Baseline, 1-month, 3-month, 6-month
Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months	Quality of life and global assessment evaluate using a numeric rating scale (NRS) ranging from 0 to 10. Higher scores mean a worse outcome..	Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 3-months and 6-months	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.	Baseline, 3-month, 6-month
Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months	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.	Baseline, 6-month

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Demirhan Diracoglu, Prof., Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation; Principal Investigator: Ekin I Sen, Asst. Prof., Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: knee osteoarthritis; platelet rich plasma
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: Istanbul Universty PRP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No