Clinical trial NCT03879434: Routine Application of Ostenil® Mini in Patients with Rhizarthrosis
Official title: Routine Application of Ostenil® Mini in Patients with Rhizarthrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhizarthrosis
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change of Pain Intensity compared to Baseline (VAS-slider)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to Day 252 after the last injection
measure: Change of Key Pinch Strength compared to Baseline (Pinch Gauge)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
measure: Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)
timeFrame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis für Orthopädie und Unfallchirurgie
city: Berlin
country: Germany
facility: Orthopädie am Tauentzien
city: Berlin
country: Germany
facility: MVZ Berlin Freiheit 1
city: Berlin
country: Germany
facility: Orthopädie am Kiesteich
city: Berlin
country: Germany
facility: Wirbelsäulen Gelenk Zentrum Westend
city: Berlin
country: Germany
facility: Orthopädie Wannsee
Study officials:
References: