Osteoarthritis, Ankle Clinical Trial
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
| Verified date | February 2022 |
| Source | Anika Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | September 24, 2021 |
| Est. primary completion date | September 24, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z. | Ústí Nad Labem | |
| Poland | NZOZ MEDI-SPATZ M.Spatz | Gliwice | |
| Poland | SPORTO sp. z o.o | Lódz | |
| Poland | Przychodnia Rodzinna na Sadowej | Torun |
| Lead Sponsor | Collaborator |
|---|---|
| Anika Therapeutics, Inc. |
Czechia, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Numerical Rating Scale (NRS) Pain on Walking | Reduction of Index Ankle Numerical Rating Scale (NRS) Pain on Walking from baseline post injection was obtained from participant responses. The NRS Pain Score ranged from 0 = No Pain to 10 = Worst Pain Level. A negative value for the change in Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. | 6 months | |
| Secondary | American Orthopaedic Foot and Ankle Society (AOFAS) Score | The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information in three parts to evaluate Pain, Function and Alignment. Patients report their pain (40 points), and function (50 points), and an evaluator assesses alignment (10 points). A total score is calculated by adding the three scores for a final range from 0 (worst clinical status) to 100 points (best clinical status).
A positive increase in value for the change in AOFAS score indicates improvement. A larger positive value indicates a higher level of improvement, and a better outcome. |
6 Months | |
| Secondary | Patient Global Assessment (PGA) Score | The change from baseline in ankle 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) ankle is bothering them today . The PGA Score is a validated 11-point Likert scale ranged 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. |
6 Months | |
| Secondary | The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index | 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 subjects 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. |
6 Months | |
| Secondary | Usage of Rescue Medication (Acetaminophen/Paracetamol) | The usage of Rescue Medication (RM) as based on the number of participants at 6 Months post treatment that 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. |
6 Months |