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

Not Applicable

Completed

Conditions: Osteoarthritis, Shoulder

Interventions: Device: Cingal

Registration Number: NCT04640961

Lead Sponsor: Anika Therapeutics, Inc.

Brief Summary: 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: Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cingal	Cingal	Single injection of Cingal into the shoulder joint of subjects diagnosed with osteoarthritis of the shoulder.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) Pain	6 months	Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline to 6 months post injection was obtained from participant responses. The NRS Pain Score is an 11-point Likert scale ranged from 0 = No Pain to 10 = Worst Pain level. A negative value for the change in NRS Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome.

Secondary Outcome Measures

Name	Time	Method
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.	6 Months	The usage of Rescue Medication (RM) as based on the number of participants at 6 Months post treatmentthat were NOT using acetominophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
Disabilities of the Arm, Shoulder and Hand (DASH) Score	6 Months	Improvement in pain and function in the index shoulder from baseline to 6 months as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores for each question range from 0 (no pain or disability) to 100 (most severe pain or disability) and are averaged to calculate the final DASH score from 0 to 100. A negative value for the change in DASH score indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.
Patient Global Assessment (PGA) Score	6 Months	The change from baseline to 6 months in index shoulder pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0 = No Pain to 10 = Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome.
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment	6 Months	The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of participants that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome

Trial Locations

Locations (4): Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
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Ústí Nad Labem, Czechia
Przychodnia Rodzinna na Sadowej
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Toruń, Poland
NZOZ MEDI-SPATZ M.Spatz
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Gliwice, Poland
SPORTO sp. z o.o
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Łódź, Poland