This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.
This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU). All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.
Study Type
OBSERVATIONAL
Enrollment
201
The Parker Institute
Copenhagen, Denmark
Reumatolog i Odense
Odense, Denmark
AP-HM hopitaux
Marseille, France
Clinique Saint Louis
Poissy, France
Number of adverse events
The total number of treatment emergent adverse events
Time frame: 5 years
WOMAC pain subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
WOMAC stiffness subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
WOMAC physical function subscale
change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale
Time frame: 6, 12, 24, 36, 48 and 60 months
Patient's global assessment of impact of osteoarthritis
An eleven point, numeric rating scale (0-10) where 0 =" No impact" and 10 = "Worst imaginable impact"
Time frame: 6, 12, 24, 36, 48 and 60 months
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AmBeNet Hausarztpraxis
Leipzig, Germany
University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
Mainz, Germany
Ospedale San Pietro Fatebenefratelli
Rome, Italy
London North West University Healthcare
London, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom