Randomized Controlled Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2019; 10(9): 310-326
Published online Sep 18, 2019. doi: 10.5312/wjo.v10.i9.310
Single- and double-dose of platelet-rich plasma versus hyaluronic acid for treatment of knee osteoarthritis: A randomized controlled trial
Mehdi Tavassoli, Nasser Janmohammadi, Akram Hosseini, Soraya Khafri, Seyed Mokhtar Esmaeilnejad-Ganji
Mehdi Tavassoli, Student Research Committee, School of Medicine, Babol University of Medical Sciences, Babol 47176-47745, Iran
Nasser Janmohammadi, Department of Orthopedics, Babol University of Medical Sciences, Babol 47176-47745, Iran
Akram Hosseini, Department of Pathology, Faculty of Medicine, Babol University of Medical Sciences, Babol 47176-47745, Iran
Soraya Khafri, Biostatistics and Epidemiology Department, Medicine Faculty, Babol University of Medical Sciences, Babol 47176-47745, Iran
Seyed Mokhtar Esmaeilnejad-Ganji, Clinical Research Development Center, Shahid Beheshti Hospital, Babol University of Medical Sciences, Babol 47176-47745, Iran
Author contributions: Tavassoli M and Esmaeilnejad-Ganji SM contributed in study design; Janmohammadi N, Hosseini A and Khafri S contributed in advising on study design; Tavassoli M and Esmaeilnejad-Ganji SM contributed to data collection; Khafri S contributed in data analysis; Tavassoli M and Hosseini A contributed in writing the draft; Esmaeilnejad-Ganji SM and Janmohammadi N contributed in manuscript revision; all authors approved the final version of the manuscript.
Supported by Vice Chancellor for Research and Technology of Babol University of Medical Sciences, No. 970568.
Institutional review board statement: This study was reviewed and approved by the Ethical Research Committee of Babol University of Medical Sciences (code: IR.MUBABOL.HRI.REC.1397.082).
Clinical trial registration statement: This trial was registered in the Iranian Registry of Clinical Trials with the number IRCT20180129038548N1.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare that they have no conflict of interest to declare.
CONSORT 2010 statement: The manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Seyed Mokhtar Esmaeilnejad-Ganji, MD, Associate Professor, Department of Orthopedics, Babol University of Medical Sciences, Ganjafrooz Street, Babol 47176-47745, Mazandaran, Iran. smsnganji@yahoo.com
Telephone: +98-11-32199936 Fax: +98-11-32190181
Received: March 6, 2019
Peer-review started: March 8, 2019
First decision: April 16, 2019
Revised: May 10, 2019
Accepted: August 12, 2019
Article in press: August 13, 2019
Published online: September 18, 2019
Research background

Knee osteoarthritis is the most common articular disease that manifests as functional pain and joint stiffness, leading to disability in the elderly. More than 10% of the people aged ≥ 60 years suffer from this disease.

Research motivation

Hyaluronic acid is a therapeutic option for knee osteoarthritis. However, it has short-term effects on control of symptoms. Platelet-rich plasma (PRP) is also suggested for treatment of knee osteoarthritis. However, evidence about the clinical use of PRP is still insufficient. Investigations comparing the efficacy of these two drugs together are also insufficient.

Research objectives

The objective of this study was to compare the therapeutic efficacy of intra-articular injection of two different doses of PRP versus hyaluronic acid in three groups of patients with knee osteoarthritis.

Research methods

This single-blinded randomized controlled trial study involved 95 patients with bilateral knee osteoarthritis. Thirty-one subjects received a single injection of PRP (group PRP-1), 33 subjects received two injections of PRP at an interval of 3 wk (group PRP-2) and 31 subjects received three injections of hyaluronic acid at 1-wk intervals (group hyaluronic acid). The patients were investigated prospectively at the enrollment and at 4-, 8- and 12-wk follow-up with the Western Ontario and McMaster Universities Arthritis Index and Visual Analogue Scale questionnaires.

Research results

In the groups PRP-1, PRP-2 and hyaluronic acid, 86%, 100% and 0% of the patients, respectively experienced at least a 30% decrease in the total score for the Western Ontario and McMaster Universities Arthritis Index pain subscale from baseline to wk 12 of the intervention (P < 0.001). The mean total Western Ontario and McMaster Universities Arthritis Index scores for groups PRP-1, PRP-2 and hyaluronic acid at baseline were 63.71, 61.57 and 63.11, respectively, which were significantly improved at final follow-up to 42.5, 35.32 and 57.26, respectively. The highest efficacy of PRP was observed in both groups at wk 4 with about a 50% decrease in the symptoms compared with about a 25% decrease for the hyaluronic acid group. Group PRP-2 had higher efficacy than group PRP-1. No major adverse effects were found during the study.

Research conclusions

PRP is a safe and efficient therapeutic option for treatment of knee osteoarthritis (significantly better than hyaluronic acid). The efficacy of PRP increases after multiple injections.

Research perspectives

Future studies with longer follow-up are suggested to evaluate long-term efficacy and potential compactions. We also propose that future studies use magnetic resonance imaging to assess and quantify cartilage regeneration if costs and ethical issues allow.