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 hip joint.
Single injection into the hip 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Single injection into the hip 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 Hip Numerical Rating Scale (NRS) Pain on Walking 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.
Time frame: 6 months
Lequesne Hip Index
Improvement from baseline to 6 months in The Lequesne Hip Index. The Lequesne Hip Index is a three-section patient questionnaire that evaluates (1) pain or discomfort, (2) maximum distance walked, and (3) activities of daily living with 0 = best results / normal scores, to scores \>14 = extremely severe, to a maximum index score of 24 points. A negative value for the change in Lequesne Hip Index indicates improvement. A larger negative 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 hip 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) hip 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
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.
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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