NCT06113783

Assessment of Efficacy of a Single Intra-articular Injection of HYALUBRIX 60 in Knee Osteoarthritis

A Post-market, Randomized, Controlled Clinical Investigation to Assess the Efficacy of HYALUBRIX 60® Intra-articular Injection in the Symptomatic Relief of Knee Osteoarthritis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).

Detailed description

Knee Osteoarthritis (OA) is one of the primary causes of pain and disability worldwide, associated with functional restrictions, morphological changes in the subchondral bone, articular cartilage degeneration and damage to the surrounding soft tissue. \[Heiden TL, 2009; Di Cesare PE, 2009, Fernandes L, 2013\]. In the degradation of articular cartilage, functional limitation and pain, underlies the quantitative and qualitative alteration of hyaluronic acid (HA), the main component of synovial fluid and cartilage, in a pathophysiological process influenced by a wide variety of risk factors \[Balazs, E.A, 1993\]. In OA patients, HA is depolymerized and eliminated faster than in healthy subjects, due to chronic inflammation \[Legré-Boyer, V., 2015\]. HA concentration is significantly decreased in patients with end-stage knee OA \[Bagga, H et al, 2006\]. HA used intra-articularly in the treatment of OA is known to increase viscosity of the synovial fluid, facilitate gliding via layer formation on the cartilage and protect soft tissue from trauma by acting as a shock absorbent \[Legré-Boyer et al., 2015; Cooper et al., 2017; Bowman et al., 2018\]. HA also soothes the pain and exerts an immunomodulatory effect on inflammatory cells \[Pelletier, J.P, 1993\]. HA has a delayed onset of action in comparison with IA corticosteroids, but a longer-lasting benefit \[Bannuru, R.R., 2009\]. HYALUBRIX 60® is a CE-marked medical device of class III consisting in a 1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight. HYALUBRIX 60® exhibits a behavior very similar to the synovial fluid that it replaces. In particular, it confers proper rheological properties, trans-synovial fluid buffering, and permeability to metabolites and macromolecules. This post-market, monocentre, randomized, controlled clinical investigation is designed to enrol a relatively young, active population of subjects with knee OA and to compare responses to treatment with one IA HYALUBRIX 60® injection plus physical exercise program (PEP), versus a PEP alone. Because PEP or exercise programs may be considered the first line standard of care in OA knee pain, particularly in younger, active patients \[Nelson AE et al. 2014\], the hypothesis of the study is that HYALUBRIX 60® combined to PEP, provides greater relief of pain associated with knee OA in the enrolled study subjects than with use of PEP alone. The primary endpoint pain relief is measured after 2 months, but observation will last up to 12 months and effects on both pain relief and physical function will be evaluated at 1, 2, 6, and 12 months after single injection (in the HYALUBRIX 60® treated arm), through WOMAC index. Selection of dose was done on the basis of a previous randomised clinical trial (RCT) (Clementi et al, 2018) conducted on 50 patients, that showed no significant difference between the two groups (single injection and injection repeated after 3-4 weeks) for beneficial long-term pain relief and functional improvement in terms of VAS score, WOMAC score and Lequesne index at 1, 3, 6 and 12 months. A clinical improvement was observed as early as at 1 month in each treatment group and continued until 1 year with no difference in the development over time between the two treatment groups.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	HYALUBRIX 60	1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight.

Timeline

• Start date: 2022-06-16
• Primary completion: 2024-12-01
• Completion: 2026-03-01
• First posted: 2023-11-02
• Last updated: 2024-07-29

Locations

1 site across 1 country: Italy