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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puri Raharja Hospital

Denpasar, Bali, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Procedure

2 ml of platelet rich plasma intraarticular injection twice in one week interval

Other names: T_Biyoteknoloji LTD, Turkey

Normal Saline

Other

NaCl 0.9%

Other names: NaCl 0.9%

Primary outcomes

WOMAC

Time frame: 2 weeks

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire

Sponsors and collaborators

Lead sponsor

Universitas Bali Internasional

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Feb 10, 2023
Registry last updated: Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed