Clinical trial NCT04640974: Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint
Official title: A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Ankle Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Ankle
Keywords: Sodium Hyaluronate
Triamcinolone Hexacetonide
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 ankle joint.

Detailed description: Single injection into the ankle 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).

Eligibility criteria: Screening Inclusion Criteria:

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

Baseline Inclusion Criteria

1. NRS pain on walking ≥4 and ≤ 9 in index ankle

Screening Exclusion Criteria:

1. History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids
2. Infection or skin disease in the area of the injection site or ankle joint
3. NRS pain on walking \> 3 in the contralateral ankle
4. NRS pain on walking \> 3 in the ipsilateral knee or hip
5. 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.
6. 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.
7. 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.
8. 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.
9. Significant trauma to the index ankle within 26 weeks of screening
10. Chronic use of narcotics or cannabis.
11. Ligament instability or tear in index ankle.
12. Chronic impingement in the index ankle requiring surgical treatment
13. Diagnosis of fibromyalgia
14. Diagnosis of osteonecrosis in index ankle
15. Subject has significant varus or valgus deformity greater than 10 degrees in either knee.
16. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
17. Uncontrolled diabetes with HbA1c of \>7%.
18. 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.
19. Subject is receiving or in litigation for worker's compensation.
20. Otherwise determined by the investigator to be medically unsuitable for participation in this study.

Baseline Exclusion Criteria

1. Subject has a decrease of ≥ 2 in the NRS pain on walking from Screening to Baseline in the index ankle.
2. Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain on Walking
timeFrame: 6 months
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Score
timeFrame: 6 Months
measure: Patient Global Assessment (PGA) Score
timeFrame: 6 Months
measure: The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment.
timeFrame: 6 Months
measure: Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
city: Gliwice
country: Poland
facility: NZOZ MEDI-SPATZ M.Spatz
city: Toruń
country: Poland
facility: Przychodnia Rodzinna na Sadowej
city: Łódź
country: Poland
facility: SPORTO sp. z o.o
Study officials:
affiliation: Anika Therapeutics
name: Kara Mezger
role: STUDY_DIRECTOR
References: