Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint

Study Overview
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Brief Summary
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This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal® used for the symptomatic relief of osteoarthritis in the shoulder joint.

Detailed Description
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CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe. Cingal will be injected into the intraarticular (IA) space of the index hip using an 18-21-gauge needle. It is used for the symptomatic relief of osteoarthritis in the shoulder joint.

Official Title
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A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint

Conditions
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Osteoarthritis, Shoulder

Intervention / Treatment
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* Device: Cingal


Participation Criteria
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Eligibility Criteria
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Screening Inclusion Criteria Age 18 years or older Body Mass Index (BMI) ≤ 35 kg/m2 Diagnosis of symptomatic osteoarthritic joint in the index shoulder (Kellgren-Lawrence grade I to III or Guyette grade I to III) to be treated with CINGAL injection. Failed conservative treatment for joint osteoarthritis. NRS pain ≥4 and ≤9 in the index shoulder. Subject must be willing to abstain from other treatments of the index shoulder 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 assessment, 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. Baseline Inclusion Criteria 1. NRS pain ≥4 and ≤9 in index shoulder Screening Exclusion Criteria: History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids Infection or skin disease in the area of the injection site or index shoulder NRS pain > 3 in the contralateral shoulder 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 shoulder 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 shoulder only) corticosteroid within 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 shoulder within 26 weeks of screening. Chronic use of narcotics or cannabis. Baseline Exclusion Criteria Subject has a decrease of ≥ 2 in the NRS pain from Screening to Baseline in the index shoulder. Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cingal<br> | Device: Cingal<br>* CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of index shoulder Numerical Rating Scale (NRS) pain | (0 to 10 with 0 No Pain and 10 Worst Pain) on walking from baseline to 6 months post injection. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium Hyaluronate, Triamcinolone Hexacetonide