Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, platelet rich plasma
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, 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
Interventions
OTHERIntra-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.
OTHERIntra-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.
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.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline activity pain score at 1-months, 3-months and 6-months | Baseline, 1-month, 3-month, 6-month | Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline activity pain score at 1-months, 3-months and 6-months | Baseline, 1-month, 3-month, 6-month | Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome |
| Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months | 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. |
| Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months | 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.. |
| Change from baseline functional balance at 3-months and 6-months | 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. |
| Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORDemirhan Diracoglu, Prof.
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
PRINCIPAL_INVESTIGATOREkin I Sen, Asst. Prof.
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Outcome results
None listed