Study of Cingal for Symptomatic Relief of Osteoarthritis of Ankle Joint

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    25
  • sponsor
    Anika Therapeutics, Inc.
Updated on 3 February 2021

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 ankle joint.

Description

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 ankle joint.

Details
Condition Osteoarthritis Ankle
Treatment Cingal
Clinical Study IdentifierNCT04640974
SponsorAnika Therapeutics, Inc.
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Body Mass Index (BMI) 35 kg/m2
Diagnosis of symptomatic osteoarthritic joint in the index ankle (Kellgren-Lawrence grade I to III) to be treated with Cingal injection
Failed conservative treatment for joint osteoarthritis
NRS pain on walking 4 and 9 in the index ankle
Subject must be willing to abstain from other treatments of the index ankle 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 visit, 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
NRS pain on walking 4 and 9 in index ankle

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 ankle joint
NRS pain on walking > 3 in the contralateral ankle
NRS pain on walking > 3 in the ipsilateral knee or hip
Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either ankle 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 ankle 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 ankle 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 ankle only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index ankle is allowed
Significant trauma to the index ankle within 26 weeks of screening
Chronic use of narcotics or cannabis
Ligament instability or tear in index ankle
Chronic impingement in the index ankle requiring surgical treatment
Diagnosis of fibromyalgia
Diagnosis of osteonecrosis in index ankle
Subject has significant varus or valgus deformity greater than 10 degrees in either knee
Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable
Uncontrolled diabetes with HbA1c of >7%
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
Subject is receiving or in litigation for worker's compensation
Otherwise determined by the investigator to be medically unsuitable for participation in this study
Baseline Exclusion Criteria
Subject has a decrease of 2 in the NRS pain on walking from Screening to Baseline in the index ankle
Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate
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