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

NCT05722626 | Completed DMC

• 1 other identifier: 01_028/UNBI/EC/V/2021
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• WOMAC

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

  2 weeks

Study Arms (2)

Platelet-rich plasma

EXPERIMENTAL

PRP manufactured by T\_Biyoteknoloji LTD, Turkey

Procedure: PRP

Normal Saline

PLACEBO COMPARATOR

NaCl 0.9%

Other: Normal Saline

Interventions

PRP PROCEDURE

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

Also known as: T_Biyoteknoloji LTD, Turkey

Platelet-rich plasma

Normal Saline OTHER

NaCl 0.9%

Also known as: NaCl 0.9%

Normal Saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Bali Internasional: lead

Study Sites (1)

Puri Raharja Hospital

Denpasar, Bali, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anak Agung Sagung Mirah Prabandari, dr.

  Warmadewa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ida Ayu Ratih Wulansari Manuaba

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)