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Single intra-articular injection of lightly cross-linked hyaluronic acid reduces knee pain in symptomatic knee osteoarthritis: a multicenter, double-blind, randomized, placebo-controlled trial

  • Stephanie C. Petterson
  • Kevin D. PlancherEmail author
Knee

Abstract

Purpose

The primary objective was to demonstrate the safety and effectiveness of Monovisc™ in the relief of joint pain in patients with idiopathic knee OA compared to saline injection. It was hypothesized that patient success, defined as ≥ 50% improvement from baseline and ≥ 20 mm absolute improvement from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) visual analog scale (VAS) pain score, would be greater in the Monovisc™ group compared to the Saline control group.

Methods

In this multicenter, double-blind, randomized, placebo-controlled trial, patients with idiopathic, symptomatic, knee OA were randomized to either 4 ml single injection of Monovisc™ or 4 ml injection of 0.9% saline. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to assess patient outcomes at 2, 4, 8, 12, 20, and 26 weeks post-injection. The primary effectiveness endpoint was a 50% improvement and ≥ 20 mm improvement from baseline in the WOMAC pain through 26 weeks. Secondary outcome measures included a ≥ 20 mm improvement from baseline on the WOMAC physical function, patient global assessment, evaluator global assessment, and knee range of motion.

Results

369 patients (154 male, 215 female) were randomized to either Monovisc™ or saline. The Monovisc™ group had a significantly greater rate of patient success (e.g. ≥ 50% improvement and ≥ 20 mm absolute improvement from baseline in the WOMAC pain through Week 26) compared to saline (p = 0.043).

Conclusions

Monovisc™, a single-injection intra-articular HA device, is a safe and effective treatment for providing a clinically meaningful reduction in knee pain within 2 weeks. The results of this study support the use of a single injection of hyaluronic acid (Monovisc™) for patients with symptomatic knee OA in patients older than 45 years, as a safe and effective alternative for patients who may want an alternative treatment modality or may not be candidates for partial or total knee replacement.

Level of evidence

I, multicenter, double-blind, randomized, placebo-controlled trial.

Keywords

Monovisc™ Hyaluronic acid Knee osteoarthritis Intra-articular injection Knee joint pain 

Abbreviations

OA

Osteoarthritis

WOMAC

Western Ontario and McMaster Universities Osteoarthritis Index

VAS

Visual analog scale

US

United States

NSAIDS

Non-steroidal anti-inflammatory medications

HA

Hyaluronic acid

USD

United States dollar

AAOS

American Academy of Orthopaedics

IRB

Institutional Review Board

GCP

Good clinical practice

ICH

International Conference on Harmonization

BMI

Body mass index

K–L

Kellgren–Lawrence

MedDRA

Medical Dictionary for Regulatory Activities

ITT

Intent-to-treat

PP

Per protocol

GEE

Generalized estimating equations

MCID

Minimum clinically important differences

ROM

Range of motion

ACR

American College of Rheumatology

OARSI

Osteoarthritis Research Society International

Notes

Acknowledgements

The authors would like to personally thank all the principal investigators and study coordinators for their help with subject recruitment and data collection. Special thanks go to Dr. Baraf, Dr. Covall, Dr. Kivitz, and Dr. Neustadt for their assistance in the completion of this manuscript and to Gary Stevens for his assistance with the data analysis.

Author contribution

Drs. Stephanie Petterson and Kevin Plancher were responsible for all aspects of manuscript development and submission.

Funding

This manuscript is based upon clinical trial results from a study sponsored by Anika Therapeutics.

Compliance with ethical standards

Conflict of interest

Grants or other financial support were received from Anika Therapeutics.

Ethical approval

Ethics committee approvals were obtained.

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Copyright information

© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2018

Authors and Affiliations

  1. 1.Orthopaedic FoundationStamfordUSA
  2. 2.Albert Einstein College of Medicine/Montefiore Hospital, Plancher Orthopaedics and Sports MedicineNew YorkUSA

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