CLINICAL EFFICACY AND SAFETY OF NEOIAL HC (HYALURONIC ACID + COLLAGEN) FOR INTRA-ARTICULAR USE IN THE TREATMENT OF SEVERE KNEE OSTEOARTHRITIS

R. Buda, MD¹, D. Bruni¹, A. Pantalone¹, D. Di Palma¹ and L. Perazzo²

¹Orthopedic and Traumatology Clinic “Ss. Annunziata” Hospital, Chieti, Italy;
²Accredited Private Hospital, “Villa Laura”, Bologna, Italy

Correspondence to:
Roberto Buda, MD PhD,
Orthopedic and Traumatology Operative Unit Complex,
“Ss. Annunziata” Hospital,
Via dei Vestini,
66100 Chieti (CH) Italy
e-mail: roberto.buda@unich.it

Received: 25 February 2024 Accepted: 11 April 2024

ISSN 2975-044X (online) ISSN 2038-4106 (print) Copyright © by BIOLIFE 2024 This publication and/or article is for individual use only and may not be further reproduced without written permission from the copyright holder. Unauthorized reproduction may result in financial and other penalties. Disclosure: All authors report no conflicts of interest relevant to this article.

ABSTRACT

                 Osteoarthritis (OA) is a common cause of pain and disability in adults, with at least 40% of individuals over 65 experiencing symptomatic OA of the hip or knee, according to the Osteoarthritis Research Society International (OARSI). Knee OA is the eleventh leading cause of years lived with disability, as reported by the World Health Organization. Current guidelines recommend using intra-articular injections of hyaluronic acid (HA) to treat OA, which can provide slow and prolonged pain relief for up to six months after the first injection. However, there is limited literature regarding the intra-articular use of isolated collagen or its combination with HA for treating knee OA. The present study (pre-market clinical trial) reports a clinically safe profile. It provides evidence of the efficacy of a viscosupplementation solution containing collagen type I, and HA obtained via bacterial fermentation (NEOIAL HC) in treating symptomatic knee OA. The primary endpoint was the safety and efficacy parameters of NEOIAL HC in intra-articular infiltration to treat severe knee osteoarthritis. The evaluation was conducted through subjective and objective clinical scores and reporting of adverse events. The secondary endpoint will be knee function 6 months after treatment. The preliminary findings suggest sustained benefits in pain and physical function from the cycle of collagen Type I and HA injections.

KEYWORDS: hyaluronic acid, knee osteoarthritis, viscosupplementation, collagen