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NCT05722626 Clinical Trial

The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:
The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05722626
Other study ID # 01_028/UNBI/EC/V/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2022

Study information
Verified date February 2023
Source Universitas Bali Internasional
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PRP
2 ml of platelet rich plasma intraarticular injection twice in one week interval
Other:
• Normal Saline
NaCl 0.9%

Locations
Country Name City State
Indonesia Puri Raharja Hospital Denpasar Bali

Sponsors (1)
Lead Sponsor Collaborator
Universitas Bali Internasional

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary WOMAC The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire 2 weeks
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