NCT04204278

MONOVISC for Ankle 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 Ankle 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

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

Detailed description

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 ankle joint. The entire study duration from first subject in to last subject out will be approximately one and half years. The enrollment phase will be approximately 12 months with a follow-up phase of 6 months. Visits will be scheduled at screening, baseline, 1 month, 3 months and 6 months post treatment.

Conditions

• Osteoarthritis Ankle

Interventions

Type	Name	Description
DEVICE	Monovisc	A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.

Timeline

• Start date: 2019-12-11
• 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