Clinical trial NCT04757051: Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
Official title: Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.

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 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)

Primary outcomes:
measure: Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline
timeFrame: week 1, week 12, week 24, week 36
measure: Change of pain intensity compared to baseline (visual analogue scale, VAS)
timeFrame: week 1, week 12, week 24, week 36
measure: Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)
timeFrame: week 1, week 12, week 24, week 36
measure: Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)
timeFrame: week 1, week 12, week 24, week 36
measure: Responder rate according to OMERACT-OARSI criteria
timeFrame: week 24
measure: Incidence of treatment-emergent Adverse Events
timeFrame: Up to week 36
measure: Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)
timeFrame: week 1, week 12, week 24, week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Praxiszentrum Elisengalerie
Study officials:
affiliation: Praxiszentrum Elisengalerie
name: Dr. med. Eichhorn
role: PRINCIPAL_INVESTIGATOR
References: