Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis

TRB Chemedica

Status: Completed

Conditions: Knee Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT04757051

BEN-PMCF-DE-2020

Details and patient eligibility

About

PMCF study to assess the effectiveness and safety of BENART in the treatment of symptomatic knee OA in a real-life clinical setting when used according to the instructions for use.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female aged between 18 and 99 years
• diagnosis of symptomatic knee OA: Kellgren & Lawrence grade II/III
• physician's recommendation to use BENART TM prior to recruitment
• signed informed consent

Exclusion criteria

• known allergy or hypersensitivity to any of the BENART TM components
• infection or skin disease at or around the injection site
• severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)
• history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)
• evidence of lymphatic or venous stasis or serious blood disorders
• known pregnancy or breast feeding
• significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)
• individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)