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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

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