Back to resultsIntraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee (PRP)
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Leukocyte-rich platelet-rich plasma
Leukocyte-poor platelet-rich plasma
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring OA knee, PRP, Leukocyte concentration, Osteoarthritis Knee
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks. Exclusion Criteria: 1) Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb < 12 g/dl, plt < 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus > 15, varus > 20, flexion ROM < 90 , extension lag > 20) 7) Pregnancy and lactation
Sites / Locations
- Queen Savang Vadhana Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Leukocyte-rich platelet-rich plasma
Leukocyte-poor platelet-rich plasma
Corticosteroid
Arm Description
Leukocyte-rich PRP: Centrifuge at 300 G for 5 min, separate the plasma and buffy coat layers, and then centrifuge at 700 G for 17 min with calcium chloride at the ratio of 1:5 to PRP by volume.
Leukocyte-poor PRP: Centrifuge at 123 G for 15 min, separate the plasma and buffy coat layers, and then centrifuge at 448 G for 10 min. Calcium chloride was added 1:5 to PRP by volume.
Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.
Outcomes
Primary Outcome Measures
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
a self-administered questionnaire consisting of 24 items divided into 3 subscales
Pain (5 items) Stiffness (2 items) Physical Function (17 items)
Secondary Outcome Measures
VAS pain
total of 10 score
the time up and go test
unit: second
30-second chair stand test
unit second
Full Information
NCT ID
NCT05737173
First Posted
February 12, 2023
Last Updated
February 12, 2023
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT05737173
Brief Title
Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee
Acronym
PRP
Official Title
Comparison Efficacy of Intraarticular Knee Injection in Knee Osteoarthritis With Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment
Detailed Description
Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP), leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
OA knee, PRP, Leukocyte concentration, Osteoarthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leukocyte-rich platelet-rich plasma
Arm Type
Experimental
Arm Description
Leukocyte-rich PRP: Centrifuge at 300 G for 5 min, separate the plasma and buffy coat layers, and then centrifuge at 700 G for 17 min with calcium chloride at the ratio of 1:5 to PRP by volume.
Arm Title
Leukocyte-poor platelet-rich plasma
Arm Type
Experimental
Arm Description
Leukocyte-poor PRP: Centrifuge at 123 G for 15 min, separate the plasma and buffy coat layers, and then centrifuge at 448 G for 10 min. Calcium chloride was added 1:5 to PRP by volume.
Arm Title
Corticosteroid
Arm Type
Experimental
Arm Description
Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.
Intervention Type
Drug
Intervention Name(s)
Leukocyte-rich platelet-rich plasma
Other Intervention Name(s)
LRPRP
Intervention Description
Intra-articular knee injection
Intervention Type
Drug
Intervention Name(s)
Leukocyte-poor platelet-rich plasma
Other Intervention Name(s)
LPPRP
Intervention Description
Intra-articular knee injection
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
CS
Intervention Description
Intra-articular knee injection
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
a self-administered questionnaire consisting of 24 items divided into 3 subscales
Pain (5 items) Stiffness (2 items) Physical Function (17 items)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
VAS pain
Description
total of 10 score
Time Frame
6 months
Title
the time up and go test
Description
unit: second
Time Frame
6 months
Title
30-second chair stand test
Description
unit second
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks.
Exclusion Criteria:
1) Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb < 12 g/dl, plt < 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus > 15, varus > 20, flexion ROM < 90 , extension lag > 20) 7) Pregnancy and lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surapol Athiprayul, MD
Organizational Affiliation
Queen Savang Vadhana Memorial Hospital, Thailand
Official's Role
Study Director
Facility Information:
Facility Name
Queen Savang Vadhana Memorial Hospital
City
Si Racha
State/Province
Chonburi
ZIP/Postal Code
20110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12081113
Citation
Kuptniratsaikul V, Tosayanonda O, Nilganuwong S, Thamalikitkul V. The epidemiology of osteoarthritis of the knee in elderly patients living an urban area of Bangkok. J Med Assoc Thai. 2002 Feb;85(2):154-61.
Results Reference
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PubMed Identifier
25035839
Citation
Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18.
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30623236
Citation
Huang Y, Liu X, Xu X, Liu J. Intra-articular injections of platelet-rich plasma, hyaluronic acid or corticosteroids for knee osteoarthritis : A prospective randomized controlled study. Orthopade. 2019 Mar;48(3):239-247. doi: 10.1007/s00132-018-03659-5.
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Learn more about this trial
Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee
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