Efficacy and Safety of Sinovial®HL Single Injection in the Knee Osteoarthritis

The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.

Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sporto Clinic

Lodz, 90 - 038, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria

medical indication for viscosupplementation therapy with hybrid HA 2 patients aged between 45 and 80 years 3.diagnosis of gonarthrosis 4. gonarthrosis symptoms for at least 6 months 5. patients who failed to respond to analgesics and/or regular NSAIDs, 6. grade 2 to 3 OA in the Kellgren-Lawrence grading scale 7. pain on walking measured by the Visual Analog Scale (VAS; 0-100 mm) of at least 40 mm on the targeted knee; 8. contralateral knee pain when walking with aVAS of less than 10 mm.

The exclusion criteria were:

inability to understand the aim of the study
inability to provide acceptable consent
pregnancy
serious psychiatric disorders
allergy or intolerance to hybrid HA
secondary gonarthrosis due to systematic and inflammatory disorders.

Treatment and study plan

Sinovial

Drug

A single intra-articular injection of hybrid HA complex, Sinovial® HL (IBSA Pharmaceuticals, Italy, patent number WO/2012/032151 ) in the knee was performed from the lateral approach to the suprapatellar recess using ultrasound. For the ultrasound-guided infiltration method, a sterile linear probe with a 20 G guide was used to visualize the joint suprapatellar recess and avoid intrasynovial infiltration. The patient was positioned supine with the knee in full extension. From the lateral approach to the suprapatellar recess, HA was then injected into the knee joint, verifying intra-articular positioning in real-time via ultrasound imaging (direct visualization of viscous fluid or air bubbles).

Patients did not receive anti-inflammatory or pain-relieving drugs in the week before the first injection . Patients were evaluated at four time points: at baseline and after 28, 42, 84, and 168 days after the intervention. At each evaluation, clinical data relating to the status of the disea

Primary outcomes

Visual Analog Scale

Time frame: 6 month

Visual Analog Scale for the assessment of the pain during the study. Scale 0 ( no pain ) to 10 ( extreme pain )
The Western Ontario and McMaster Universities Arthritis Index

Time frame: 6 months

The Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) is used to assess the function of the knee in osteoarthritis. Scale 0 ( the worst result ) -100 ( the best result )

Sponsors and collaborators

Lead sponsor

Marcin Domżalski

Other

Collaborators

IBSA Institut Biochimique SA

Registry information

Official study title

Real-world Efficacy and Safety of Sinovial®HL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis: an Observational Study

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 22, 2024
Registry last updated: Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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