Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

Study Overview
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Brief Summary
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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.

Official Title
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Routine Application of Ostenil® Mini in Patients With Rhizarthrosis

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Device: Ostenil® Mini


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ostenil® Mini<br>1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval. | Device: Ostenil® Mini<br>* Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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 |