MONOVISC for Shoulder Joint Pain Relief

Osteo Arthritis Shoulders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204265
• Other study ID #: MON 18-02
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 30, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Czechia	Krajská zdravotní, a.s.	Ústí nad Labem
Poland	Nzoz Medi-Spatz	Gliwice
Poland	SPORTO	Lódz
Poland	Przychodnia Rodzinna na Sadowej	Torun

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Reduction in Medication usage	Reduction in Medication usage from baseline to 6 months post injection	From baseline to 6 months