MONOVISC for Shoulder Joint Pain Relief

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

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Shoulders
• Intervention / Treatment: Device: Monovisc

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Ústí nad Labem, Czechia
    • Krajska Zdravotni, a.s.
• Poland
  • Gliwice, Poland
    • Nzoz Medi-Spatz
  • Toruń, Poland
    • Przychodnia Rodzinna na Sadowej
  • Łódź, Poland
    • SPORTO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or older
2. Body Mass Index (BMI) ≤ 45 kg/m2
3. Diagnosis of symptomatic osteoarthritic joint in the index joint (Kellgren Lawrence grade I to III or Guyette grade I to III) to be treated with MONOVISC injection.
4. Failed conservative treatment for joint osteoarthritis.
5. NRS pain ≥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 > 3 in the contralateral joint
4. 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.
5. 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.
6. 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.
7. 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.
8. Significant trauma to the index shoulder within 26 weeks of screening
9. Chronic use of narcotics or cannabis.
10. Ligament instability or tear in index joint.
11. Diagnosis of fibromyalgia
12. Diagnosis of osteonecrosis in index joint
13. Uncontrolled diabetes with HbA1c of >7%.
14. 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.
15. Subject is receiving or in litigation for worker's compensation.
16. Otherwise determined by the investigator to be medically unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Monovisc	Device: Monovisc; A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose in a 5-mL glass syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of index joint Numerical Rating Scale (NRS 0-10 0 No Pain, 10 Worst Pain) pain	Reduction of index joint Numerical Rating Scale (NRS) pain from baseline to 6 Months post injection.	From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Patient Global Assessment (PGA) (0-10 0 No Pain, 10 Worst Pain)	Improvement in Patient Global Assessment (PGA) from baseline to 6 months post injection.	From baseline to 6 months
OMERACT-OARSI responder rate in the index joint	OMERACT-OARSI responder rate in the index joint at 6 months post injection.	From baseline to 6 months
Reduction in Medication usage	Reduction in Medication usage from baseline to 6 months post injection	From baseline to 6 months
Improvement in DASH (Disabilities of Arm, Shoulder & Hand 0-100 0 No Disability, 100 Worst Disability) index	Improvement in DASH index from baseline to 6 months post injection.	from baseline to 6 months

Collaborators and Investigators

• Sponsor: Anika Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Sodium Hyaluronate
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MON 18-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No