MONOVISC for Ankle Joint Pain Relief Due to Osteoarthritis

NCT ID: NCT04204278

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2021-03-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monovisc

Single injection of MONOVISC into the index ankle joint

Group Type: EXPERIMENTAL

Monovisc

Intervention Type: DEVICE

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

Interventions

Monovisc

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older

2. Body Mass Index (BMI) ≤ 35 kg/m2

3. Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren-Lawrence grade I to III) to be treated with MONOVISC injection.

4. Failed conservative treatment for joint osteoarthritis.

5. NRS pain on walking ≥4 and ≤9 in the index joint.

6. Subject must be willing to abstain from other treatments of the index joint for the duration of the study.

7. 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.

8. 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.

9. 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).

10. Able and willing to provide signed informed consent.

Exclusion Criteria

1. History of hypersensitivity to any of the ingredients in the hyaluronan

2. Infection or skin disease in the area of the injection site or index joint

3. NRS pain on walking > 3 in the contralateral joint

4. NRS pain on walking > 3 in the ipsilateral knee or hip

5. 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.

6. 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.

7. 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.

8. 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.

9. Significant trauma to the index ankle within 26 weeks of screening

10. Chronic use of narcotics or cannabis.

11. Ligament instability or tear in index joint.

12. Chronic impingement in the index joint requiring surgical treatment

13. Diagnosis of fibromyalgia

14. Diagnosis of osteonecrosis in index joint

15. Subject has significant varus or valgus deformity greater than 10 degrees in either knee.

16. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.

17. Uncontrolled diabetes with HbA1c of >7%.

18. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.

19. Subject is receiving or in litigation for worker's compensation.

20. Otherwise determined by the investigator to be medically unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anika Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kara Mezger

Role: STUDY_DIRECTOR

Anika Therapeutics

Locations

Krajská zdravotní, a.s.

Ústí nad Labem, , Czechia

Nzoz Medi-Spatz

Gliwice, , Poland

SPORTO

Lodz, , Poland

Przychodnia Rodzinna na Sadowej

Torun, , Poland

Countries

Czechia; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MON 18-03

Identifier Type: -

Identifier Source: org_study_id