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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: PRP; Other: Normal Saline

• Registration Number: NCT05722626
• Lead Sponsor: Universitas Bali Internasional

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma	PRP	PRP manufactured by T_Biyoteknoloji LTD, Turkey
Normal Saline	Normal Saline	NaCl 0.9%

Primary Outcome Measures

Name	Time	Method
WOMAC	2 weeks	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire

Trial Locations

Locations (1)

Puri Raharja Hospital; 🇮🇩 Denpasar, Bali, Indonesia