Rhizarthrosis
Conditions
Brief summary
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.
Interventions
DEVICEOstenil® Mini
Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation
Sponsors
TRB Chemedica AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Intensity compared to Baseline (VAS-slider) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain) |
| Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale |
| Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale |
| Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse) |
| Incidence of Treatment-Emergent Adverse Events | Up to Day 252 after the last injection | — |
| Change of Key Pinch Strength compared to Baseline (Pinch Gauge) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Measurement of Key Pinch in kilograms with a Pinch Gauge |
| Change of Tip Pinch Strength compared to Baseline (Pinch Gauge) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Measurement of Tip Pinch in kilograms with a Pinch Gauge |
| Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection | Measurement of Palmar Pinch in kilograms with a Pinch Gauge |
Countries
Germany
Outcome results
None listed