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 range

18 Years – 99 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 99 Years

Sex

ALL

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