MONOVISC for Ankle Joint Pain Relief Due to Osteoarthritis

NCT04204278 | Completed Results

• 1 other identifier: MON 18-03
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Osteoarthritis Ankle

Keywords

Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Pain on Walking

  Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

  Baseline to 6 Months

Secondary Outcomes (4)

• American Orthopaedic Foot and Ankle Society (AOFAS) Score

  Baseline to 6 Months

• Patient Global Assessment (PGA) Score

  Baseline to 6 Months

• The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

  6 Months

• Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)

  6 Months

Study Arms (1)

Monovisc

EXPERIMENTAL

Single injection of MONOVISC into the index ankle joint

Device: Monovisc

Interventions

Monovisc DEVICE

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

Monovisc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Body Mass Index (BMI) ≤ 35 kg/m2
• Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with MONOVISC injection.
• Failed conservative treatment for joint osteoarthritis.
• NRS pain on walking ≥4 and ≤9 in the index joint.
• Subject must be willing to abstain from other treatments of the index joint for the duration of the study.
• Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
• Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol.
• Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF).
• Able and willing to provide signed informed consent.

You may not qualify if:

• History of hypersensitivity to any of the ingredients in the hyaluronan
• Infection or skin disease in the area of the injection site or index joint
• NRS pain on walking \> 3 in the contralateral joint
• NRS pain on walking \> 3 in the ipsilateral knee or hip
• Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study.
• Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index joint or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.
• Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
• Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index joint only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed.
• Significant trauma to the index ankle within 26 weeks of screening
• Chronic use of narcotics or cannabis.
• Ligament instability or tear in index joint.
• Chronic impingement in the index joint requiring surgical treatment
• Diagnosis of fibromyalgia
• Diagnosis of osteonecrosis in index joint
• Subject has significant varus or valgus deformity greater than 10 degrees in either knee.

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (4)

Krajská zdravotní, a.s.

Ústí nad Labem, Czechia

Location

Nzoz Medi-Spatz

Gliwice, Poland

Location

SPORTO

Lodz, Poland

Location

Przychodnia Rodzinna na Sadowej

Torun, Poland

Location

Limitations and Caveats

There were no limitations or caveats associated with the conduct of this trial.

Results Point of Contact

• Title: Kara Mezger, Executive Director Clinical Affairs
• Organization: Anika Therapeutics

kmezger@anika.com

781.457.9000

Study Officials

• Kara Mezger

  Anika Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: December 11, 2019
• Primary Completion: February 26, 2021
• Study Completion: March 30, 2021
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2025-01

Locations

CZ (1); PL (3)