PRP Effectiveness in Knee Osteoarthritis (PRP)
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intra-articular T-LAB / PRP KIT injection
Intra-articular T-LAB / PRP INJECTION SYRINGE injection
Intra-articular SALINE injection
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, platelet rich plasma
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
Sites / Locations
- Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
T-LAB / PRP KIT
T-LAB / PRP INJECTION SYRINGE
SALINE
Arm Description
In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT injection in 3 sessions will be applied.
In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied.
In the first group, Platelet-rich plasma (PRP) prepared with SALINE injection in 3 sessions will be applied.
Outcomes
Primary Outcome Measures
Change from baseline activity pain score at 1-months and 6-months
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Secondary Outcome Measures
Change from baseline rest pain score at 1-months and 6-months
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Change from baseline night pain score at 1-months and 6-months
Visual Analogue Scale-Night pain (0-10 point). Higher scores mean a worse outcome
Change from baseline pain, stiffness and physical function at 1-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 up, with a possible score range 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 functional balance at 1-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 m 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
Distal femoral cartilage thickness will be evaluated by the same clinician using the MyLab60 model ultrasonography device and high-resolution 7-12 MHz linear probe available in our clinic. During the measurement, patients will be positioned in the prone position with their knees in full flexion and ankles in neutral to examine the distal femoral cartilage, and the probe will be placed in the axial position in the suprapatellar area at the outer edge of the patella. After the distal femoral cartilage is anechogenically imaged between the hyperechogenic bony cortex and suprapatellar fat, 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 will be measured and recorded as the thickness of the cartilage. Cartilage thickness measurements for each intervention knee will be recorded by recording three measurements from the midpoint: lateral condyle, intercondylar area and medial condyle.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04807270
Brief Title
PRP Effectiveness in Knee Osteoarthritis
Acronym
PRP
Official Title
Efficacy of Two Different Platelet Rich Plasma Methods in Patients With Knee Osteoarthritis: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T-LAB / PRP KIT
Arm Type
Active Comparator
Arm Description
In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT injection in 3 sessions will be applied.
Arm Title
T-LAB / PRP INJECTION SYRINGE
Arm Type
Active Comparator
Arm Description
In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied.
Arm Title
SALINE
Arm Type
Active Comparator
Arm Description
In the first group, Platelet-rich plasma (PRP) prepared with SALINE injection in 3 sessions will be applied.
Intervention Type
Other
Intervention Name(s)
Intra-articular T-LAB / PRP KIT injection
Intervention Description
Intra-articular 3 ml T-LAB / PRP KIT injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intervention Type
Other
Intervention Name(s)
Intra-articular T-LAB / PRP INJECTION SYRINGE injection
Intervention Description
Intra-articular 3 ml T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Intervention Type
Other
Intervention Name(s)
Intra-articular SALINE injection
Intervention Description
Intra-articular 3 ml SALINE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
Primary Outcome Measure Information:
Title
Change from baseline activity pain score at 1-months and 6-months
Description
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 6-month
Secondary Outcome Measure Information:
Title
Change from baseline rest pain score at 1-months and 6-months
Description
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 6-month
Title
Change from baseline night pain score at 1-months and 6-months
Description
Visual Analogue Scale-Night pain (0-10 point). Higher scores mean a worse outcome
Time Frame
Baseline, 1-month, 6-month
Title
Change from baseline pain, stiffness and physical function at 1-months and 6-months
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range 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.
Time Frame
Baseline, 1-month, 6-month
Title
Change from baseline functional balance at 1-months and 6-months
Description
The Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 m 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.
Time Frame
Baseline, 1-month, 6-month
Title
Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months
Description
Distal femoral cartilage thickness will be evaluated by the same clinician using the MyLab60 model ultrasonography device and high-resolution 7-12 MHz linear probe available in our clinic. During the measurement, patients will be positioned in the prone position with their knees in full flexion and ankles in neutral to examine the distal femoral cartilage, and the probe will be placed in the axial position in the suprapatellar area at the outer edge of the patella. After the distal femoral cartilage is anechogenically imaged between the hyperechogenic bony cortex and suprapatellar fat, 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 will be measured and recorded as the thickness of the cartilage. Cartilage thickness measurements for each intervention knee will be recorded by recording three measurements from the midpoint: lateral condyle, intercondylar area and medial condyle.
Time Frame
Baseline, 6-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinan Gok, MD
Phone
+902124142000
Ext
12856
Email
sinan.gok@istanbul.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yunus Emre Dogan, MD
Phone
+902124142000
Ext
12856
Email
emredogan91@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demirhan Diracoglu, Prof.
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ekin I Sen, Asst. Prof.
Organizational Affiliation
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
State/Province
Fatıh
ZIP/Postal Code
34034
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinan Gok, MD
Phone
+902124142000
Ext
12856
Email
sinan.gok@istanbul.edu.tr
First Name & Middle Initial & Last Name & Degree
Ekin I Sen, Asst. Prof.
Phone
+902124142000
Ext
12856
Email
ekinozgorgu@gmail.com
First Name & Middle Initial & Last Name & Degree
Ekin I Sen, Asst. Prof
First Name & Middle Initial & Last Name & Degree
Demirhan Diracoglu, Profesor
First Name & Middle Initial & Last Name & Degree
Yunus Emre Dogan, MD
First Name & Middle Initial & Last Name & Degree
Sinan Gok, MD
12. IPD Sharing Statement
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PRP Effectiveness in Knee Osteoarthritis
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