Clinical Trials Directory

Trials / Completed

CompletedNCT04204265

MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis

A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate (MONOVISC) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Anika Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Obtain real world, post market data to confirm the clinical improvement and safety in patients treated with a single injection of MONOVISC for the symptomatic relief of osteoarthritis in the shoulder joint.

Detailed description

The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for shoulder osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving shoulder joint pain to 6 months post-treatment.

Conditions

Interventions

TypeNameDescription
DEVICEMonoviscA chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.

Timeline

Start date
2019-12-17
Primary completion
2021-02-26
Completion
2021-03-30
First posted
2019-12-18
Last updated
2025-01-28
Results posted
2025-01-28

Locations

4 sites across 2 countries: Czechia, Poland

Source: ClinicalTrials.gov record NCT04204265. Inclusion in this directory is not an endorsement.