Platelet-rich Plasma and Synovial Cytokines in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intra-articular injection of platelet-rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Platelet rich plasma, Knee osteoarthritis, MRI Osteoarthritis Knee Score, pain score, synovial fluid, tumor necrosis factor-α, macrophage migration inhibitory factor
Eligibility Criteria
Inclusion Criteria:
• All patients have unilateral knee OA
Exclusion Criteria:
- Polyarticular disease.
- Knee arthroscopy in the previous year.
- HA or steroid IA penetration in the preceding 3 months.
- History of infectious disease and autoimmune disorders such as diabetes, rheumatoid arthritis.
- Hematologic diseases (coagulopathy).
- Serious cardiovascular diseases , infections or immunodepression.
- Anticoagulant therapy or an anti-aggregating agent.
- Uuse of non-steroidal anti-inflammatory drugs 2 weeks prior to blood sampling.
- < 10 g / dL of hemoglobin
Sites / Locations
- Faculty of Medicine, South valley University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mild knee osteoarthritis
Moderate knee osteoarthritis
Severe knee osteoarthritis
Arm Description
30 patients had mild knee osteoarthritis
30 patients had moderate knee osteoarthritis
30 patients had severe knee osteoarthritis
Outcomes
Primary Outcome Measures
Changes in Pain Scores in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).
Using Visual Analog Scale (VAS) score to assess the pain score in patients with knee osteoarthritis will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.
The VAS is a common tool that uses a 10 cm scale for pain intensity measurement, where 0= no pain and 10= unable to move.
Changes in the synovial fluid concentration of the TNF-α and MIF levels folllowing PRP injection, using ELISA assay kits.
Using ELISA assay kits, synovial fluid concentration of both TNF-α and MIF levels will be measured three times for the same patient (before injection, 2 weeks from the first injection and 2 weeks from the second injection) to explore the serial changes in their levels following IA i injection PRP.
Changes in MRI Osteoarthritis Knee Score (MOAKS) in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).
Regarding MRI knee score will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.
For assessment of both bone marrow abnormality or patella-femoral cartilage volume (grade I (mild if the lesion involves ˂33% of subregional volume); grade II (Moderate: if the lesion involves 33%- 66% of subregional volume), and grade III (severe: if the lesion involves ˃ 66% of subregional volume).Regarding synovitis: grade 1 (mild or small - fluid continuous in the retropatellar space); grade 2 (Moderate or medium - slight convexity of the suprapatellar bursa), and grade 3 (severe or large - evidence of capsular distension ). Meniscal desintegrity score of 0-3 applied for amount of extrusion in 4 locations: medial meniscus (medial and anterior extrusion) and lateral meniscus (medial and anterior extrusion).
Assess the correlations of synovial fluid TNF-α and MIF levels with both pain and radiological scores will performed among these patients.
Correlate visual Analog pain Scale and MRI Osteoarthritis Knee Score with the pre-injection cytokine synovial levels and synovial level values 2 weeks from the second IA injection of PRP
Secondary Outcome Measures
Full Information
NCT ID
NCT04754685
First Posted
February 5, 2021
Last Updated
February 11, 2021
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04754685
Brief Title
Platelet-rich Plasma and Synovial Cytokines in Knee Osteoarthritis
Official Title
Assessments of Therapeutic Effects of Platelet-rich Plasma in Knee Osteoarthritis: Possible Role of Inflammatory Cytokines
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley 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
A prospective study was performed on 90 patients were included and categorized into mild (30 cases, moderate (30 cases) and severe (30 cases) knee OA. Three intra-articular (I.A) injections of PRP, 2 weeks a part, were received. Pain score and MRI Osteoarthritis Knee Score (MOAKS) were assessed. Serial synovial fluid cytokines assays in the form of Tumor necrosis factor-α (TNF-α) and Macrophage migration inhibitory factor (MIF), were performed using commercially available ELISA assay kits. The assays were performed pre-injection (S1), two weeks from the 1st I.A injection and two weeks from the 2nd I.A injection (S3) for all included patients.
Detailed Description
Background: Osteoarthritis (OA) is a multifactorial disease that commonly affects the knee. Tumor necrosis factor-α (TNF-α) is able to regulate inflammation in OA. Macrophage migration inhibitory factor (MIF) may be involved in the pathophysiology of arthritis. Platelet-rich plasma (PRP) may reduce pain associated with OA. The current study aimed to assess the possible therapeutic effects of PRP in patients with knee OA of various severities.
Methods: A prospective study was performed on 90 patients were included and categorized into mild (30 cases, moderate (30 cases) and severe (30 cases) knee OA. Three intra-articular (I.A) injections of PRP, 2 weeks a part, were received. Pain score and MRI Osteoarthritis Knee Score (MOAKS) were assessed. Serial synovial fluid cytokines assays in the form of Tumor necrosis factor-α (TNF-α) and Macrophage migration inhibitory factor (MIF), were performed using commercially available ELISA assay kits. The assays were performed pre-injection (S1), two weeks from the 1st I.A injection and two weeks from the 2nd I.A injection (S3) for all included patients.
PRP preparation: The PRP needed for IA injection has been prepared under complete aseptic conditions. In order to avoid the effect of food intake on purified PRP, on the day of injection the patients were instructed to fast for 4 hours before blood collection. Approximately 20 mL of venous blood were drawn from the antecubital vein using an aseptic technique in an effort to avoid irritation and trauma to the platelets. Anti-coagulated blood was obtained in ten extraction tubes (2 mL each), containing sodium citrate. The tubes were then centrifuged at 2100 rpm at room temperature for 8 minutes to separate the blood in each tube into the citrated plasma, the buffy coat and the residual red blood cells ( RBCs) . Using a pipette, the PRP situated just above the selectively precipitated RBCs but not including the buffy coat was carefully aspirated from each tube. In each affected joint, 10-mL PRP samples (from the collected venous blood) were used for IA injection . For each intra-articular injection new fresh PRP samples were made from the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Platelet rich plasma, Knee osteoarthritis, MRI Osteoarthritis Knee Score, pain score, synovial fluid, tumor necrosis factor-α, macrophage migration inhibitory factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective study was performed on 90 patients were included and categorized into mild (30 cases, moderate (30 cases) and severe (30 cases) knee OA. Three intra-articular (I.A) injections of PRP, 2 weeks a part, were received. Pain score and MRI Osteoarthritis Knee Score (MOAKS) were assessed. Serial synovial fluid cytokines assays in the form of Tumor necrosis factor-α (TNF-α) and Macrophage migration inhibitory factor (MIF), were performed using commercially available ELISA assay kits. The assays were performed pre-injection (S1), two weeks from the 1st I.A injection and two weeks from the 2nd I.A injection (S3) for all included patients.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild knee osteoarthritis
Arm Type
Active Comparator
Arm Description
30 patients had mild knee osteoarthritis
Arm Title
Moderate knee osteoarthritis
Arm Type
Active Comparator
Arm Description
30 patients had moderate knee osteoarthritis
Arm Title
Severe knee osteoarthritis
Arm Type
Active Comparator
Arm Description
30 patients had severe knee osteoarthritis
Intervention Type
Drug
Intervention Name(s)
Intra-articular injection of platelet-rich plasma
Other Intervention Name(s)
PRP injection
Intervention Description
The patient was put in 20 degree flexion in supine position with the knee. Under aseptic conditions, a 21-gage needle was used to inject 5 mL of PRP into the suprapatellar knee joint pouch, using a superolateral method. Local anesthetics were not used. Patients were instructed after the injection to refrain from physical exercise for at least 24 hours but no restriction was specified regarding activities of daily living. Three IA-PRP injections were administered at 2-week intervals. The same physician who was engaged in selecting and testing participants did the injections
Primary Outcome Measure Information:
Title
Changes in Pain Scores in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).
Description
Using Visual Analog Scale (VAS) score to assess the pain score in patients with knee osteoarthritis will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.
The VAS is a common tool that uses a 10 cm scale for pain intensity measurement, where 0= no pain and 10= unable to move.
Time Frame
one year
Title
Changes in the synovial fluid concentration of the TNF-α and MIF levels folllowing PRP injection, using ELISA assay kits.
Description
Using ELISA assay kits, synovial fluid concentration of both TNF-α and MIF levels will be measured three times for the same patient (before injection, 2 weeks from the first injection and 2 weeks from the second injection) to explore the serial changes in their levels following IA i injection PRP.
Time Frame
one year
Title
Changes in MRI Osteoarthritis Knee Score (MOAKS) in patients with various severities of knee OA following intra-articular injection of PRP at 0, and 2 weeks from the second injection (0,4 weeks).
Description
Regarding MRI knee score will be done twice , pre-intra-articular injection of PRP and 2 weeks from the second I.A injection of PRP.
For assessment of both bone marrow abnormality or patella-femoral cartilage volume (grade I (mild if the lesion involves ˂33% of subregional volume); grade II (Moderate: if the lesion involves 33%- 66% of subregional volume), and grade III (severe: if the lesion involves ˃ 66% of subregional volume).Regarding synovitis: grade 1 (mild or small - fluid continuous in the retropatellar space); grade 2 (Moderate or medium - slight convexity of the suprapatellar bursa), and grade 3 (severe or large - evidence of capsular distension ). Meniscal desintegrity score of 0-3 applied for amount of extrusion in 4 locations: medial meniscus (medial and anterior extrusion) and lateral meniscus (medial and anterior extrusion).
Time Frame
one year
Title
Assess the correlations of synovial fluid TNF-α and MIF levels with both pain and radiological scores will performed among these patients.
Description
Correlate visual Analog pain Scale and MRI Osteoarthritis Knee Score with the pre-injection cytokine synovial levels and synovial level values 2 weeks from the second IA injection of PRP
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• All patients have unilateral knee OA
Exclusion Criteria:
Polyarticular disease.
Knee arthroscopy in the previous year.
HA or steroid IA penetration in the preceding 3 months.
History of infectious disease and autoimmune disorders such as diabetes, rheumatoid arthritis.
Hematologic diseases (coagulopathy).
Serious cardiovascular diseases , infections or immunodepression.
Anticoagulant therapy or an anti-aggregating agent.
Uuse of non-steroidal anti-inflammatory drugs 2 weeks prior to blood sampling.
< 10 g / dL of hemoglobin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed H Hassan, MD
Organizational Affiliation
Faculty of Medicine- South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, South valley University
City
Qena
ZIP/Postal Code
83523
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29581613
Citation
Taniguchi Y, Yoshioka T, Kanamori A, Aoto K, Sugaya H, Yamazaki M. Intra-articular platelet-rich plasma (PRP) injections for treating knee pain associated with osteoarthritis of the knee in the Japanese population: a phase I and IIa clinical trial. Nagoya J Med Sci. 2018 Feb;80(1):39-51. doi: 10.18999/nagjms.80.1.39.
Results Reference
result
PubMed Identifier
21645627
Citation
Hunter DJ, Guermazi A, Lo GH, Grainger AJ, Conaghan PG, Boudreau RM, Roemer FW. Evolution of semi-quantitative whole joint assessment of knee OA: MOAKS (MRI Osteoarthritis Knee Score). Osteoarthritis Cartilage. 2011 Aug;19(8):990-1002. doi: 10.1016/j.joca.2011.05.004. Epub 2011 May 23. Erratum In: Osteoarthritis Cartilage. 2011 Sep;19(9):1168.
Results Reference
result
PubMed Identifier
10352653
Citation
Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.
Results Reference
result
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Platelet-rich Plasma and Synovial Cytokines in Knee Osteoarthritis
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