RhizarthrosisNCT03879434
Routine Application of Ostenil® Mini in Patients with Rhizarthrosis
An observational study of Rhizarthrosis, run by TRB Chemedica AG at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Ostenil® Mini
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 110 participants
- Where
- 6 sitesGermany
- Study dates
- 17 Apr 2019to 16 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.
Who may be able to join
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Orthopädie am Tauentzien
Berlin, State of Berlin, 10789
Praxis für Orthopädie und Unfallchirurgie
Berlin, 10711
MVZ Berlin Freiheit 1
Berlin, 12555
Orthopädie am Kiesteich
Berlin, 13589
Wirbelsäulen Gelenk Zentrum Westend
Berlin, 14052
Orthopädie Wannsee
Berlin, 14109
About this study
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.
- Conditions
- Rhizarthrosis
- Being tested
- Ostenil® Mini
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostenil® MiniDevice
Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation
| Study group | Role | What they receive |
|---|---|---|
| Ostenil® Mini | 1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval. Receives: Device: Ostenil® Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Incidence of Treatment-Emergent Adverse Events
Measured: 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
Measured: 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
Measured: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)
Measurement of Palmar Pinch in kilograms with a Pinch Gauge
Measured: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start17 Apr 2019
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879434
- Sponsor's protocol ID
- OSTCMC-PMCF-DE-2018-01
- Status last verified
- Oct 2024
- First submitted
- 15 Mar 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Application of Ostenil® Mini in Patients with Rhizarthrosis
- ClinicalTrials.gov ID
- NCT03879434
- Acronym / sponsor ID
- OSTCMC-PMCF-DE-2018-01
- Conditions
- Rhizarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostenil® Mini | – | Device: Ostenil® Mini1-3 injections of sodium hyaluronate 1.0 % (10 milligrams (mg) / 1,0 millilitres (ml)) in weekly interval. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil® Mini.
Key inclusion criteria (3 listed)
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ostenil® MiniOstenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation | Device | Ostenil® Mini |
Primary outcome
Change of Pain Intensity compared to Baseline (VAS-slider)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Up to Day 252 after the last injection
Change of Key Pinch Strength compared to Baseline (Pinch Gauge)
Time frame: 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)
Time frame: 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)
Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Measurement of Palmar Pinch in kilograms with a Pinch Gauge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhizarthrosis, run by TRB Chemedica AG at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Intensity compared to Baseline (VAS-slider) (time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.