Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.
U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy
RECRUITINGReduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain)
Time frame: Up to 180 days
Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The total score is the result of the sum of 3 groups of questions with 5 possible answers (between 0 and 4, where 0=none and 4=extreme) for the self-assessment of: * pain:five questions (score from 0 to 20); * joint stiffness: two questions (score from 0 to 8); * functional limitations: 17 questions (score from 0 to 68).
Time frame: Up to 180 days
Improved range of motion (ROM) of the knee joint
The variation of the ROM joint excursion used for the analysis of the joint excursion (flexion-extension), will be calculated as the difference between maximum width and minimum width of the angular profile on the basis of the following formula: ROMα = max (α) - min (α) (flexion-extension)
Time frame: Up to 180 days
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