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

U

Universitas Bali Internasional

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Procedure: PRP
Other: Normal Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05722626
01_028/UNBI/EC/V/2021

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

106 participants in 2 patient groups, including a placebo group

Platelet-rich plasma
Experimental group
Description:
PRP manufactured by T_Biyoteknoloji LTD, Turkey
Treatment:
Procedure: PRP
Normal Saline
Placebo Comparator group
Description:
NaCl 0.9%
Treatment:
Other: Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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