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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Platelet-rich plasma

PRP manufactured by T\_Biyoteknoloji LTD, Turkey

Group Type EXPERIMENTAL

PRP

Intervention Type PROCEDURE

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

Normal Saline

NaCl 0.9%

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

NaCl 0.9%

Interventions

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PRP

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

Intervention Type PROCEDURE

Normal Saline

NaCl 0.9%

Intervention Type OTHER

Other Intervention Names

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T_Biyoteknoloji LTD, Turkey NaCl 0.9%

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No