Status:
COMPLETED
Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
Lead Sponsor:
TRB Chemedica AG
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04757051
Start Date
March 11 2021
End Date
April 25 2022
Last Update
August 3 2022
Active Locations (1)
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1
Praxiszentrum Elisengalerie
Aachen, Germany, 52062