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.
Study Type
OBSERVATIONAL
Enrollment
110
Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation
Orthopädie am Tauentzien
Berlin, State of Berlin, Germany
Praxis für Orthopädie und Unfallchirurgie
Berlin, Germany
MVZ Berlin Freiheit 1
Berlin, Germany
Orthopädie am Kiesteich
Berlin, Germany
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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Incidence of Treatment-Emergent Adverse Events
Time frame: 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
Time frame: 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
Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wirbelsäulen Gelenk Zentrum Westend
Berlin, Germany
Orthopädie Wannsee
Berlin, Germany
Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)
Measurement of Palmar Pinch in kilograms with a Pinch Gauge
Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection