GonarthrosisNCT03734315
Routine Application of Ostenil® in Patients with Gonarthrosis
An observational study of Gonarthrosis, run by TRB Chemedica AG at 6 sites in Germany.
Trial summary
PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Ostenil®
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 115 participants
- Where
- 6 sitesGermany
- Study dates
- 8 Jan 2019to 12 Jan 2023
- 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: Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.
Who may be able to join
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® recommendation for the treatment of gonarthrosis
Who cannot join
- Known hypersensitivity to one of the Ostenil® components
- Presence of articular effusion in study-relevant knee joint
- Known pregnancy or lactating females
- 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 Altheimer Eck
München, Bavaria, 80331
Orthopädie München
München, Bavaria, 80331
Orthopädische Praxis am Isartor
München, Bavaria, 80331
MVZ am Nordbad
München, Bavaria, 80797
Orthopädische Praxis
München, Bavaria, 80993
Orthopädisches Versorgungszentrum München-Ost
Munich, Bavaria, 81825
About this study
PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.
- Conditions
- Gonarthrosis
- Being tested
- Ostenil®
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostenil®Device
Ostenil® 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® | 3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. Receives: Device: Ostenil® |
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 equals the worst pain.
Measured: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Change of Range of Motion compared to Baseline (Goniometer measurement)
Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.
Measured: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.
Measured: Day 84, Day 168
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 21, Day 28, Day 84, Day 168, Day 252
Incidence of Treatment-Emergent Adverse Events
Measured: Up to Day 252
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start8 Jan 2019
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Krüger-Franke, Dr. med., Principal investigator, MVZ am Nordbad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734315
- Sponsor's protocol ID
- OSTK-PMCF-DE-2018-01
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2018
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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® in Patients with Gonarthrosis
- ClinicalTrials.gov ID
- NCT03734315
- Acronym / sponsor ID
- OSTK-PMCF-DE-2018-01
- Conditions
- Gonarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 7 Nov 2018 (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® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostenil® | – | Device: Ostenil®3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 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
- Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.
Key inclusion criteria (3 listed)
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® recommendation for the treatment of gonarthrosis
Key exclusion criteria (5 listed)
- Known hypersensitivity to one of the Ostenil® components
- Presence of articular effusion in study-relevant knee joint
- Known pregnancy or lactating females
- 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®Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation. | Device | Ostenil® |
Primary outcome
Change of Pain Intensity compared to Baseline (VAS-slider)
Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain.
Change of Range of Motion compared to Baseline (Goniometer measurement)
Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168
Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.
Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline
Time frame: Day 84, Day 168
Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.
Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252
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
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.
- Individual participant dataSharing planned: No
Related trials for Gonarthrosis
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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.
Michael Krüger-Franke, Dr. med. principal investigator
MVZ am Nordbad
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 Gonarthrosis, 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 21, Day 28, Day 84, Day 168, Day 252). The study lists 5 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.