CompletedNot Applicable

Routine Application of Ostenil® Mini in Patients with Rhizarthrosis

Germany110 participantsStarted 2019-04-17

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change of Pain Intensity compared to Baseline (VAS-slider)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

Incidence of Treatment-Emergent Adverse Events

Timeframe: Up to Day 252 after the last injection

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

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

Trial details

NCT IDNCT03879434

SponsorTRB Chemedica AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-16

View on ClinicalTrials.gov More Rhizarthrosis trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change of Pain Intensity compared to Baseline (VAS-slider)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection

Incidence of Treatment-Emergent Adverse Events

Timeframe: Up to Day 252 after the last injection

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

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