NCT04661111

Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome

Prospective, Monocentric, Study to Assess Efficacy and Safety of Hymovis® ONE (32 mg/4 ml) Intra-articular Injection in Active Patients Affected by Knee Overuse Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.

Detailed description

There are no studies in literature up to now, that analyze the changes in knee pain and correlate this parameter with knee function and biomechanics, in regular casual sport player subject affected by knee overuse syndrome and underwent an intra-articular HA injection. The aim of this study is to evaluate efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Hymovis® ONE (32 mg/4 ml)	Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.

Timeline

• Start date: 2016-06-13
• Primary completion: 2017-09-28
• Completion: 2018-06-28
• First posted: 2020-12-10
• Last updated: 2020-12-10

Locations

1 site across 1 country: Italy