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

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

September 10, 2022

Study Completion Date

November 11, 2022

Conditions
Osteoarthritis of Knee
Interventions
DRUG

Sinovial

"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"

Trial Locations (1)

90 - 038

Sporto Clinic, Lodz

Sponsors
All Listed Sponsors
collaborator

IBSA Institut Biochimique SA

INDUSTRY

lead

Marcin Domżalski

OTHER

NCT06652893 - Efficacy and Safety of Sinovial®HL Single Injection in the Knee Osteoarthritis | Biotech Hunter | Biotech Hunter