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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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).
Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
Ústí nad Labem, Czechia
NZOZ MEDI-SPATZ M.Spatz
Gliwice, Poland
SPORTO sp. z o.o
Lodz, Poland
Przychodnia Rodzinna na Sadowej
Torun, Poland
Numerical Rating Scale (NRS) Pain on Walking
Reduction of Index Ankle Numerical Rating Scale (NRS) Pain on Walking from baseline to 6 months 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.
Time frame: 6 months
American Orthopaedic Foot and Ankle Society (AOFAS) Score
The change from baseline to 6 months in the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System, 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.
Time frame: 6 Months
Patient Global Assessment (PGA) Score
The change from baseline to 6 months 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.
Time frame: 6 Months
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment.
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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.
Time frame: 6 Months
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
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.
Time frame: 6 Months