Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
NCT04661111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2020-12-10
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Fidia Farmaceutici s.p.a.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-13
- Primary Completion
- 2017-09-28
- Completion
- 2018-06-28
Countries
- Italy
Study Locations
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