Knee Osteoarthritis
Conditions
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.
Interventions
None listed
Sponsors
TRB Chemedica AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline | week 1, week 12, week 24, week 36 | Knee injury and Osteoarthritis Outcome Score (KOOS) to assess pain, other symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec) and knee-related Quality of Life (QoL) on a 5-point Likert scale |
| Change of pain intensity compared to baseline (visual analogue scale, VAS) | week 1, week 12, week 24, week 36 | Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain. |
| Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10) | week 1, week 12, week 24, week 36 | The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition). |
| Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10) | week 1, week 12, week 24, week 36 | The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition). |
| Responder rate according to OMERACT-OARSI criteria | week 24 | — |
| Incidence of treatment-emergent Adverse Events | Up to week 36 | — |
| Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale) | week 1, week 12, week 24, week 36 | Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied) |
Countries
Germany
Outcome results
None listed