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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline | 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 | week 1, week 12, week 24, week 36 |
| Change of pain intensity compared to baseline (visual analogue scale, VAS) | Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain. | week 1, week 12, week 24, week 36 |
| Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10) | The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition). | week 1, week 12, week 24, week 36 |
| Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10) | The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition). | week 1, week 12, week 24, week 36 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. med. Eichhorn | Praxiszentrum Elisengalerie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxiszentrum Elisengalerie | Aachen | 52062 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38498142 | Derived | Lynen NA, Eichhorn C, Portelange N, Chausson M, Weyenberg W. Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany. Rheumatol Ther. 2024 Jun;11(3):649-662. doi: 10.1007/s40744-024-00661-6. Epub 2024 Mar 18. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)
| week 1, week 12, week 24, week 36 |
| D012216 |
| Rheumatic Diseases |