Rhizarthrosis Clinical Trial
Official title:
Routine Application of Ostenil® Mini in Patients With Rhizarthrosis
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - Subjects = 18 years of age and in good general health condition - Signed informed consent - Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis Exclusion Criteria: - Known hypersensitivity to one of the Ostenil® Mini components - Known pregnancy or lactating females - Presence of coagulation disorder - Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts - Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | MVZ Berlin Freiheit 1 | Berlin | |
| Germany | Orthopädie am Kiesteich | Berlin | |
| Germany | Orthopädie am Tauentzien | Berlin | |
| Germany | Orthopädie Wannsee | Berlin | |
| Germany | Praxis für Orthopädie und Unfallchirurgie | Berlin | |
| Germany | Wirbelsäulen Gelenk Zentrum Westend | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| TRB Chemedica AG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Incidence of Treatment-Emergent Adverse Events | Up to Day 252 after the last injection | ||
| Primary | 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 | |
| Primary | Change of Tip Pinch Strength compared to Baseline (Pinch Gauge) | Measurement of Tip Pinch in kilograms with a Pinch Gauge | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | |
| Primary | 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 |
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