Back to resultsThe Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
PRP
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria: patients with knee pain for at least three months, aged between 40 to 80 years old, and whose results of radiological examination of the knee indicated OA grades 2-4 based on the Kellgren Lawrence classification Exclusion Criteria: polyarticular rheumatic disease; knee arthroscopy <1 year; intra-articular injection of hyaluronic acid (HA) or steroids in the past three months; current infection, diabetes, rheumatoid arthritis, coagulopathy disorders, anticoagulant or antiplatelet aggregation therapy, immunodeficiency disease, taking non-steroidal anti-inflammatory drugs (NSAIDs) two weeks prior to the procedure, knee trauma; inflammation; and tumors around the knee
Sites / Locations
- Puri Raharja Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Platelet-rich plasma
Normal Saline
Arm Description
PRP manufactured by T_Biyoteknoloji LTD, Turkey
NaCl 0.9%
Outcomes
Primary Outcome Measures
WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT05722626
First Posted
February 1, 2023
Last Updated
February 1, 2023
Sponsor
Universitas Bali Internasional
1. Study Identification
Unique Protocol Identification Number
NCT05722626
Brief Title
The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Official Title
The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Bali Internasional
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
This is a single-center, randomized control trial The aim of this study is to compare PRP with placebo as the treatment of knee OA Conducted at Puri Raharja Hospital Bali in January-June 2022 Sample consisted of 106 patients with knee OA grades 2-3 Kellgren-Lawrence, randomized into PRP group and placebo group Samples were injected with 2 ml PRP or normal saline twice at one-week interval The severity of knee OA was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before injection and two weeks after the first injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-rich plasma
Arm Type
Experimental
Arm Description
PRP manufactured by T_Biyoteknoloji LTD, Turkey
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9%
Intervention Type
Procedure
Intervention Name(s)
PRP
Other Intervention Name(s)
T_Biyoteknoloji LTD, Turkey
Intervention Description
2 ml of platelet rich plasma intraarticular injection twice in one week interval
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
NaCl 0.9%
Primary Outcome Measure Information:
Title
WOMAC
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with knee pain for at least three months, aged between 40 to 80 years old, and whose results of radiological examination of the knee indicated OA grades 2-4 based on the Kellgren Lawrence classification
Exclusion Criteria:
polyarticular rheumatic disease; knee arthroscopy <1 year; intra-articular injection of hyaluronic acid (HA) or steroids in the past three months; current infection, diabetes, rheumatoid arthritis, coagulopathy disorders, anticoagulant or antiplatelet aggregation therapy, immunodeficiency disease, taking non-steroidal anti-inflammatory drugs (NSAIDs) two weeks prior to the procedure, knee trauma; inflammation; and tumors around the knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anak Agung Sagung Mirah Prabandari, dr.
Organizational Affiliation
Warmadewa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puri Raharja Hospital
City
Denpasar
State/Province
Bali
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
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