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PMCF study to observe the routine application of Ostenil® Mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the CMC joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostenil® Mini | 1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostenil® Mini | Device | Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Intensity compared to Baseline (VAS-slider) | Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline | Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline | Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5) | The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Incidence of Treatment-Emergent Adverse Events | Up to Day 252 after the last injection | |
| Change of Key Pinch Strength compared to Baseline (Pinch Gauge) | Measurement of Key Pinch in kilograms with a Pinch Gauge | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Tip Pinch Strength compared to Baseline (Pinch Gauge) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädie am Tauentzien | Berlin | State of Berlin | 10789 | Germany | ||
| Praxis für Orthopädie und Unfallchirurgie |
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Measurement of Tip Pinch in kilograms with a Pinch Gauge |
| Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge) | Measurement of Palmar Pinch in kilograms with a Pinch Gauge | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Berlin |
| 10711 |
| Germany |
| MVZ Berlin Freiheit 1 | Berlin | 12555 | Germany |
| Orthopädie am Kiesteich | Berlin | 13589 | Germany |
| Wirbelsäulen Gelenk Zentrum Westend | Berlin | 14052 | Germany |
| Orthopädie Wannsee | Berlin | 14109 | Germany |