CoxarthrosisNCT03809962
Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
An observational study of Coxarthrosis, run by TRB Chemedica AG at 7 sites in Germany.
Trial summary
PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Ostenil® Plus
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 170 participants
- Where
- 7 sitesGermany
- Study dates
- 15 Feb 2019to 14 May 2025
- 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 Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
Who may be able to join
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® Plus recommendation for the treatment of coxarthrosis
Who cannot join
- Known hypersensitivity to one of the OSTENIL® PLUS components
- Known pregnancy or lactating females
- Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
- 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
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Gemeinschaftspraxis für Orthopädie und Unfallchirurgie
Bad Oldesloe, Schleswig-Holstein, 23843
Orthopädische Gemeinschaftspraxis Eutin
Eutin, 23701
Orthopraxis Kiel
Gettorf, Schleswig-Holstein, 24214
Orthopädische Praxis Rahlstedt
Hamburg, Free and Hanseatic City of Hamburg, 22143
Zentrum für Medizin des Bewegungsapparates
Heide, Schleswig-Holstein, 25746
Orthopädie Praxis
Ramelsloh, 21220
OrthopädieZentrum Maschen
Seevetal, 21220
About this study
PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.
- Conditions
- Coxarthrosis
- Being tested
- Ostenil® Plus
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostenil® PlusDevice
Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation
| Study group | Role | What they receive |
|---|---|---|
| Ostenil® Plus | 1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval. Receives: Device: Ostenil® Plus |
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 most pain)
Measured: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Change of Range of Motion compared to Baseline (Goniometer measurement)
Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.
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 Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale
Measured: Day 84 after last injection, Day 168 after last injection
Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale
Measured: Day 84 after last injection, Day 168 after last injection
Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale
Measured: Day 84 after last injection, Day 168 after last injection
Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale
Measured: 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 Jan 2019
- Study start15 Feb 2019
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Knut Behle, Dr. med., Principal investigator, OrthopädieZentrum MaschenDarja Becker, Dr. med., Principal investigator, Orthopädie Praxis Dr. Darja Becker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809962
- Sponsor's protocol ID
- OSTH-PMCF-DE-2018-01
- Status last verified
- Jun 2025
- First submitted
- 14 Jan 2019
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
- ClinicalTrials.gov ID
- NCT03809962
- Acronym / sponsor ID
- OSTH-PMCF-DE-2018-01
- Conditions
- Coxarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 18 Jan 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® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostenil® Plus | – | Device: Ostenil® Plus1-3 injections of sodium hyaluronate 2% (40 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
- Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
Key inclusion criteria (3 listed)
- Subjects ≥ 18 years of age and in good general health condition
- Signed informed consent
- Existing Ostenil® Plus recommendation for the treatment of coxarthrosis
Key exclusion criteria (5 listed)
- Known hypersensitivity to one of the OSTENIL® PLUS components
- Known pregnancy or lactating females
- Previous/concomitant participation in clinical investigation within the last 3 months prior to study inclusion
- 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® PlusOstenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation | Device | Ostenil® Plus |
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 equals the most pain)
Change of Range of Motion compared to Baseline (Goniometer measurement)
Time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.
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 Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline
Time frame: Day 84 after last injection, Day 168 after last injection
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale
Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline
Time frame: Day 84 after last injection, Day 168 after last injection
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale
Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline
Time frame: Day 84 after last injection, Day 168 after last injection
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale
Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline
Time frame: Day 84 after last injection, Day 168 after last injection
Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale
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 5 Jun 2025.
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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.
Knut Behle, Dr. med. principal investigator
OrthopädieZentrum Maschen
Darja Becker, Dr. med. principal investigator
Orthopädie Praxis Dr. Darja Becker
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coxarthrosis, run by TRB Chemedica AG at 7 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 5 Jun 2025.